Devices

Device Recall Sigma Pacemaker

Model / Serial
Not all serial numbers within these ranges are affected. The specific serial numbers of affected devices may be found online at http://SigmaSNList.medtronic.com. Model SDR203: serial no. PJD183978h - PJD184012h, PJD186200H - PJD186279H, PJD187571H - PJD187669H, PJD193734H, PJD195394H - PJD195470H, PJD442170H, PJD445718H - PJD452929H, PJD674175S - PJD680868S, PJD685590S, PJD689228S, PJD691226S, PJD731742S - PJD739835S. Model SDR 303: serial no. PJD182452H - PJD199059H, PJD205280H, PJD440288H - PJD451956H, PJD674216S - PJD691410S, PJD730124S - PJD746998S. Model SDR 306: serial no. JE120662H - PJE120706H, PJE620733S - PJE621387S.
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
Nationwide. and to OUS including: Europe, Australia, Canada, Hong Kong and Greater China, Japan, Latin America
Product Description
Sigma implantable pulse generators (IPGs) Dual Chamber Rate Responsive Pacemaker, models SDR203, SDR303, SDR306
Manufacturer
Medtronic Inc. Cardiac Rhythm Managment
1 Event
- Recall of Device Recall Sigma Pacemaker

Manufacturer

Medtronic Inc. Cardiac Rhythm Managment

Manufacturer Address
Medtronic Inc. Cardiac Rhythm Managment, 7000 Central Ave Ne, Fridley MN 55432
Source
USFDA

5 devices with a similar name

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Device Recall Sigma Pacemaker

Model / Serial
Not all serial numbers within these ranges are affected. The specific serial numbers of affected devices may be found online at http://SigmaSNList.medtronic.com. Model SD203: serial no. PJD182918H - PJD191025H, PJD432660H - PJD449026H, PJD674196S - PJD690881S, PJD731443S - PJD743447S. Model SD303: serial no. PJD183969H - PJD186285H, PJD187584H - PJD187735H, PJD190274H, PJD190305H, PJD190308H, PJD195395H, PJD195444H, PJD441326 - PJD448026H, PJD674200S - PJD681640S, PJD691135S, PJD691231S, PJD729895S - PJD742209S.
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
Nationwide. and to OUS including: Europe, Australia, Canada, Hong Kong and Greater China, Japan, Latin America
Product Description
Sigma implantable pulse generators (IPGs) dual Chamber Pacemaker, models SD203, SD303
Manufacturer
Medtronic Inc. Cardiac Rhythm Managment

Device Recall Sigma Pacemaker

Model / Serial
Not all serial numbers within these ranges are affected. The specific serial numbers of affected devices may be found online at http://SigmaSNList.medtronic.com. Model SVDD303: serial no. PJD183400H - PJD183447H, PJD186130H - PJD186199H, PJD188418H - PJD188519H, PJD430299H - PJD430332H, PJD441378H - PJD441396H, PJD442436H - PJD442448H, PJD445371H - PJD448139H, PJD675113S - PJD675193S, PJD675694S - PJD676809S, PJD677182S - PJD677945S, PJD678157S - PJD686906S, PJD730001S - PJD744349S.
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
Nationwide. and to OUS including: Europe, Australia, Canada, Hong Kong and Greater China, Japan, Latin America
Product Description
Sigma implantable pulse generators (IPGs) Dual Chamber Atrial Sensing, Ventricular Sensing and Pacing Pacemaker. Atrial Bipolar sensing connector, ventricular Bipolar connector, model SVDD303.
Manufacturer
Medtronic Inc. Cardiac Rhythm Managment

Device Recall Sigma Pacemaker

Model / Serial
Not all serial numbers within these ranges are affected. The specific serial numbers of affected devices may be found online at http://SigmaSNList.medtronic.com. Model SS103: serial no. PJG160592H - PJG161247H, PJG162149H - PJG162607H, PJG163245H - PJG163805H, PJG165759H - PJG168541H, PJG170637H - PJG170921H, PJG428851H - PJG431485H, PJG677154S - PJG748119S, PJG748671S - PJG748710S, PJG748732S - PJG750863S, PJG751336S - PJG751944S, PJG752070S - PJG754744S, PJG231054M - PJG233721M, PJG748407C - PJG748670C, PJG748711C - PJG748722C. Model SS106: serial no. PJH117098H - PJH118839H, PJH624138S - PJH624610S, PJH626910S - PJH626967S. Model SS203: serial no. PJG165866H, PJG170641H - PJG170782H, PJG428850H - PJG431464H, PJG676637S - PJG681858S, PJG682490S, PJG683196S, PJG684296S - PJG689861S, PJG695412S, PJG747908S - PJG754745S, PJG231551M - PJG234346M. Model SS303: serial no. PJG162131H - PJG16371H, PJG427797H - PJG431510H, PJG676969S - PJG691865, PJG740396S - PJG757886S.
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
Nationwide. and to OUS including: Europe, Australia, Canada, Hong Kong and Greater China, Japan, Latin America
Product Description
Sigma implantable pulse generators (IPGs) Single Chamber Pacemaker, models SS103, SS106, SS203, SS303
Manufacturer
Medtronic Inc. Cardiac Rhythm Managment

Device Recall Sigma Pacemaker

Model / Serial
Not all serial numbers within these ranges are affected. The specific serial numbers of affected devices may be found online at http://SigmaSNList.medtronic.com. Model SSR203: serial no. PJG159204H - PJG178395H, PJG462302H - PJG434280H, PJG740166S - PJG766757S, PJG675988S - PJG694391S. Model SSR303: serial no. PJG159103H, - PJG178395H, PJG426302H - PJG434280H, PJG740166S - PJG766757S, PJG675988S - PJG694391S. Model SSR306: serial no. PJH116644H - PJH118708H, PJH624113S - PJH627050S.
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
Nationwide. and to OUS including: Europe, Australia, Canada, Hong Kong and Greater China, Japan, Latin America
Product Description
Sigma implantable pulse generators (IPGs) Single Chamber Rate Responsive Pacemaker, models SSR203, SSR303, SSR306
Manufacturer
Medtronic Inc. Cardiac Rhythm Managment

Device Recall Sigma Pacemaker

Model / Serial
Not all serial numbers within these ranges are affected. The specific serial numbers of affected devices may be found online at http://SigmaSNList.medtronic.com. Model SVVI103: serial no.PJG159902H - PJG176701H, PJG432779H - PJG432895H, PJG230582M - PJG236398M, PJG677442S - PJG696014S, PJG748310S - PJG755468S, PJG747654C - PJG755171C.
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
Nationwide. and to OUS including: Europe, Australia, Canada, Hong Kong and Greater China, Japan, Latin America
Product Description
Sigma implantable pulse generators (IPGs) Single Chamber Pacemaker model SVVI103, for ventricular use only.
Manufacturer
Medtronic Inc. Cardiac Rhythm Managment

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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