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

Model Number	0157
Medical Device Problem Codes	High impedance (1291); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this right ventricular (rv) lead exhibited high out-of-range pace impedance measurements greater than 2,500 ohms and threshold measurements of 5.5v@2ms.It was noted that the patient had not been seen since 2016, and the last device check showed the following lead measurements: pace impedance 1,671 ohms, thresholds 2.4v at 0.4ms, and shock impedance 65 ohms.No noise was observed at that time.Technical services (ts) recommended further lead evaluation, and discussed possible causes and troubleshooting options.This rv lead remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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) lead exhibited high out-of-range pace impedance measurements greater than 2,500 ohms and threshold measurements of 5.5v@2ms.It was noted that the patient had not been seen since 2016, and the last device check showed the following lead measurements: pace impedance 1,671 ohms, thresholds 2.4v at 0.4ms, and shock impedance 65 ohms.No noise was observed at that time.Technical services (ts) recommended further lead evaluation, and discussed possible causes and troubleshooting options.This rv lead remains in service.No adverse patient effects were reported.Additional information received reported that this right ventricular (rv) defibrillation lead was surgically abandoned and replaced.It was also noted that this implantable cardioverter defibrillator (icd) was explanted and upgraded to a cardiac resynchronization therapy defibrillator (crt-d) system.No additional adverse patient effects were reported.

• 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): CPI - DEL CARIBE; guidant puerto rico b. v.; #12, rd. #698; dorado PR 00646
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16344919
• Report Number: 2124215-2023-05890
• Device Sequence Number: 6260965
• Product Code: LWS
• UDI-Device Identifier: 00802526531125
• UDI-Public: 00802526531125
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P910073/S039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2023

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: 07/12/2007
• Device Model Number: 0157
• Device Catalogue Number: 0157
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2023
• Supplement Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 02/09/2023
• Supplement Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2005
• 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: Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male