International Medical Devices Database

Data Source

Country

Device Classification

Parent Company

Name	Date	Country	Source
Safety Alert for N VISION MEDTRONIC PROGRAMMER - Model 8870 Application Software Cards used with N Vision Clinician Programmers Model 8840, Reg # 10339190180.	2004-09-24	Brazil	ANVISA
Safety Alert for ISOMED Implantable Infusion Pumps (Mod. 8472-20, 8472-35, 8472-60) and SYNCHROMED II (Mod. 8637-20 and 8637-40). Anvisa registration number: 10099430095 (ISOMED) and 10099430103 (SYNCHROMED II).	2008-05-20	Brazil	ANVISA
Safety Alert for MEDTRONIC IMPLANTABLE INFUSION PUMP. Models: SYNCHROMED II 8637-20 and 8637-40; SYNCHROMED EL 8626-10, 8626L-10, 8626-18, 8626L-18; SYNCHROMED EL 8627. Anvisa Registries No. 10339190229, 10339190104 and 10339190105.	2012-11-27	Brazil	ANVISA
Safety Alert for APPLICATION CARD OF MODEL 8870 SOFTWARE USED IN MEDICAL PROGRAMMER 8840 N VISION. Related Appliances: SYNCHROMED II IMPUTABLE INFUSION PUMP (10339190229); ACTIVE PROGRAMMABLE NEUROSTIMULATOR (10339190338); MEDTRONIC PROGRAMMABLE NEUROSTIMULATOR (10339190310); PROGRAMMER N`VISION MEDTRONIC (10339190180).	2013-10-04	Brazil	ANVISA
Safety Alert for SYNCHROMED Implantable Infusion Pump.	2015-05-15	Brazil	ANVISA
Safety Alert for Product Affected by Field Action: SynchroMed II Deployable Infusion Pump (Registration 10339190229) Models 8637-20, 8637-40 - Risk Class IV. DISTRIBUTION MAP IN ANNEX.	2016-02-29	Brazil	ANVISA
Safety Alert for Trade name: PROGRAMMER N'VISION MEDTRONIC; Medtronic Implantable Infusion Pump Technical Name: IMPLANTABLE DEVICE PROGRAMMER; Infusion Pump ANVISA registration number: 10339190180; 10339190229 Hazard Class: III; IV Model affected: 8840; Synchromed II 8637-20 / Synchromed II 8637-40	2016-12-22	Brazil	ANVISA
Safety Alert for Implanted Infusion Pump Medtronic Technical Name: Synchromed II 8637-20 / Synchromed II 8637-40 ANVISA Registration Number: 10339190229 Hazard Class: IV Affected Model: 8637-20 and 8637-40 Serial Numbers Affected: PUMP 8637 -20 SM2 20ML EMAN US JUN BATRY; PUMP 8637-20 SM2 20ML PAP MAN US JUN BAT; PUMP 8637-20 SM2 20ML PAPER MAN USMKT SL; PUMP 8637-20 SM2 20ML PAPR MAN USMKTJUNC PUMP 8637-20 SYNCH II 20ML US MKT SL; PUMP 8637-20 SYNCHMED II 20ML PF; PUMP 8637-20 SYNCHMED II PCKT FILL L105; PUMP 8637-20 SYNCHROMED II L089; PUMP 8637-20 SYNCHROMED II OUS L105; PUMP 8637-40 SYNCHMED II PCKT FILL L105; PUMP 8637-40 SYNCHROMED II L089; PUMP 8637-40 SYNCHROMED II OUS L105.	2017-04-12	Brazil	ANVISA
Safety Alert for Trade name: Synchromed II Implanted Infusion Pump. Technical Name: Infusion Pump. ANVISA registration number: 10339190229. Risk class: IV. Model affected: 8637-20 E 8637-40. Affected serial numbers: See Distribution list and Batch Affected	2017-11-17	Brazil	ANVISA
Field Safety Notices about implantable infusion pumps synchromed ii	2017-11-27	Poland	ORMPMDBP
Field Safety Notices about implantable infusion pumps synchromed ii	2016-03-16	Poland	ORMPMDBP
Field Safety Notices about implantable synchromed infusion pump	2013-06-13	Poland	ORMPMDBP
Field Safety Notices about implantable synchromed infusion pump	2013-06-14	Poland	ORMPMDBP
Field Safety Notices about implantable synchromed infusion pump	2013-06-13	Poland	ORMPMDBP
Field Safety Notices about implantable synchromed infusion pumps.	2011-01-24	Poland	ORMPMDBP
Field Safety Notices about implanted infusion pumps synchromed ii	2016-11-14	Poland	ORMPMDBP
Field Safety Notices about infusion pump synchromed ii model 8637	2017-05-18	Poland	ORMPMDBP
Field Safety Notices about infusion pumps synchromed ii.	2012-03-21	Poland	ORMPMDBP
Field Safety Notices about implantable infusion pumps synchromed ii - models 8637-20, 8637-40	2008-06-13	Poland	ORMPMDBP
Field Safety Notices about intrathecal catheters, models 8709sc, 8731sc, 8596sc, 8578, with implantable infusion pumps synchromed® and isomed®	2008-06-24	Poland	ORMPMDBP
Field Safety Notices about subcutaneous drug infusion systems synchromed and isomed.	2010-09-09	Poland	ORMPMDBP
Field Safety Notices about implanted infusion pumps synchromed ii	2009-07-14	Poland	ORMPMDBP
Field Safety Notices about model 8637 of implantable infusion pumps synchromed ii	2011-07-19	Poland	ORMPMDBP
Field Safety Notices about software card update, model 8870, and synchromed infusion system labeling	2017-02-09	Poland	ORMPMDBP
Field Safety Notices about SynchroMed EL; SynchroMed II; IsoMed	2008-03-12	Poland	ORMPMDBP

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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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