Boston Scientific Ltd:Vitality and Assure implantable cardioverter defibrillator (ICD) families and Contak Renewal cardiac resynchronisation therapy defibrillator (CRT-D) families (see Appendix 2 for full details of models affected)
TELIGENTM implantable cardioverter defibrillators (ICD) and COGNISTM cardiac resynchronisation therapy devices (CRT-D) manufactured by Boston Scientific.The manufacturer has issued a Field Safety Notice (400Kb) (FSN) in relation to the second subset of affected devices. This notice has been distributed to clinics that have implanted these devices and conduct routine patient follow-up, and also to clinics equipped with compatible programmers.Device family
Affected model numbers
COGNIS CRT-D
N106/N107/N118/N119/P106/P107/P108
TELIGEN DR ICD
E110/F110/F111
TELIGEN VR ICD
E102/F102/F103You can check specific device–serial number combinations to find out if they are affected. This look-up tool differentiates newly identified devices from those already subject to the 2013 advisory notice.
InSync III Models 8042U:Product description
Unique device identifier
IPG 8042U INSYNC III UNI INTL
00613994322524
IPG 8042U INSYNC III DC UNI EAME
00681490993364
IPG 8042U INSYNC III DC UNI EN/SV/DA
00681490993388
IPG 8042U INSYNC III DC UNI 5L
00681490993395
IPG 8042U INSYNC III DC UNI INTL
00681490993425