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

Model Number	0170
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	Calcium Deposits/Calcification (1758)
Date of Event	01/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that this right ventricular (rv) defibrillation lead exhibited a gradual rise in shock impedances to high out-of-range measurements greater than 125 ohms, with measurements as high as 146 ohms.It was noted that this trend behavior was consistent with lead calcification.The last delivered shock impedance was 48 ohms, which occurred at implant.Technical services (ts) discussed troubleshooting/programming options, including max energy shocks.This rv lead remains in service.No adverse patient effects or interventions were reported at this time.

• Brand Name: ENDOTAK RELIANCE SG
• 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: 21989354
• Report Number: 2124215-2025-29768
• Device Sequence Number: 18262724
• Product Code: LWS
• UDI-Device Identifier: 00802526373282
• UDI-Public: (01)00802526373282(17)130118
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P910073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/17/2013
• Device Model Number: 0170
• Device Catalogue Number: 0170
• Device Lot Number: 100638
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 05/08/2025
• Date Device Manufactured: 01/17/2011
• 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
• Patient Age: 42 YR
• Patient Sex: Male