MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	0157
Medical Device Problem Codes	High impedance (1291); Low impedance (2285); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Electric Shock (2554); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this right ventricular (rv) defibrillation lead triggered an alert due to a low out-of-range shock impedance measurement of 13 ohms.Technical services (ts) recommended further evaluation to rule out a potential electromagnetic interference (emi) source or consider a synch max energy shock to rule out any shorted condition.Shock lead trends from a few weeks prior note a dip in measurements from 50 ohms to 35 ohms, which may suggest the low reading was not likely attributed to emi.It was noted that no shocks have been delivered since implant.This rv lead remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
The local area field representative was contacted for additional information.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The local area field representative was contacted for additional information.If information is provided in the future, a supplemental report will be issued.-- if information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that this right ventricular (rv) defibrillation lead triggered an alert due to a low out-of-range shock impedance measurement of 13 ohms.Technical services (ts) recommended further evaluation to rule out a potential electromagnetic interference (emi) source or consider a synch max energy shock to rule out any shorted condition.Shock lead trends from a few weeks prior note a dip in measurements from 50 ohms to 35 ohms, which may suggest the low reading was not likely attributed to emi.It was noted that no shocks have been delivered since implant.This rv lead remains in service.No adverse patient effects were reported.Additional information received reported that an another shock impedance measurement taken from the same day was within normal limits.No adverse patient effects were reported.This right ventricular (rv) defibrillation lead remains in service.The patient will follow up with the electrophysiologist.
Event or Problem Description
It was reported that this right ventricular (rv) defibrillation lead triggered an alert due to a low out-of-range shock impedance measurement of 13 ohms.Technical services (ts) recommended further evaluation to rule out a potential electromagnetic interference (emi) source or consider a synch max energy shock to rule out any shorted condition.Shock lead trends from a few weeks prior note a dip in measurements from 50 ohms to 35 ohms, which may suggest the low reading was not likely attributed to emi.It was noted that no shocks have been delivered since implant.This rv lead remains in service.No adverse patient effects were reported.Additional information received reported that an another shock impedance measurement taken from the same day was within normal limits.No adverse patient effects were reported.This right ventricular (rv) defibrillation lead remains in service.The patient will follow up with the electrophysiologist.Additional information received reported that the patient was seen in clinic for furether lead evaluation.There did not appear to be any external electromagnetic interference (emi) sources.Shock impedance measurements were 0 ohms to low 20s ohms with arm movements and isometrics.Vector breakdown revealed the following measurements: rv to ra = 112 ohms, rv to can = 85 ohms, and ra to can = 200 ohms.An issue with the ra coil was suspected, and further investigation and considering possible lead revision at device replacement was recommended.At this time, the plan at this time is to program rv to can.This rv lead remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
The local area field representative was contacted for additional information.If information is provided in the future, a supplemental report will be issued.-- if information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that this right ventricular (rv) defibrillation lead triggered an alert due to a low out-of-range shock impedance measurement of 13 ohms.Technical services (ts) recommended further evaluation to rule out a potential electromagnetic interference (emi) source or consider a synch max energy shock to rule out any shorted condition.Shock lead trends from a few weeks prior note a dip in measurements from 50 ohms to 35 ohms, which may suggest the low reading was not likely attributed to emi.It was noted that no shocks have been delivered since implant.This rv lead remains in service.No adverse patient effects were reported.Additional information received reported that an another shock impedance measurement taken from the same day was within normal limits.No adverse patient effects were reported.This right ventricular (rv) defibrillation lead remains in service.The patient will follow up with the electrophysiologist.Additional information received reported that the patient was seen in clinic for further lead evaluation.There did not appear to be any external electromagnetic interference (emi) sources.Shock impedance measurements were 0 ohms to low 20s ohms with arm movements and isometrics.Vector breakdown revealed the following measurements: rv to ra = 112 ohms, rv to can = 85 ohms, and ra to can = 200 ohms.An issue with the ra coil was suspected, and further investigation and considering possible lead revision at device replacement was recommended.At this time, the plan at this time is to program rv to can.This rv lead remains in service.No adverse patient effects were reported.Additional information received reported that a 41j commanded shock was performed and the shock vector on this right ventricular (rv) defibrillation lead was updated to rv to can.Shock impedance readings were now within normal limits, and the out of range shock impedance measurements were attributed to the ra (or svc) coil.This rv lead remains in service.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
The local area field representative was contacted for additional information.If information is provided in the future, a supplemental report will be issued.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDOTAK RELIANCE
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 15349283
• Report Number: 2124215-2022-34014
• Device Sequence Number: 5203388
• Product Code: LWS
• UDI-Device Identifier: 00802526531125
• UDI-Public: 00802526531125
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P910073/S039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/27/2015
• Device Model Number: 0157
• Device Catalogue Number: 0157
• Device Lot Number: 303238
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2022
• Supplement Date Received by Manufacturer: 09/02/2022; 09/22/2022; 02/07/2023
• Initial Report FDA Received Date: 09/02/2022
• Supplement Report FDA Received Date: 09/13/2022; 10/21/2022; 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female