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

Model Number	0171
Medical Device Problem Codes	Fracture (1260); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product has been received for analysis.This report will be updated upon completion of analysis.
Event or Problem Description
It was reported that this right ventricular (rv) defibrillation lead was suspected of lead fracture, per lead testing.However, the location of the lead fracture was not determined.Subsequently, this rv lead was explanted, replaced, and returned for analysis.It was noted that the crt-d was also explanted and replaced, with no reported allegations.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, the lead was thoroughly analyzed.Visual examination confirmed that the lead was returned damaged and in three segments, severed approximately 148 millimeters (mm) from the terminal end and with some portions missing.Visual examination of the lead noted calcification of body fluids on the lead tip.Analysis determined that the increased impedance measurements may have been impacted by the calcification of body fluids on the lead.Calcification, the process in which layers of calcium build up on a surface (e.G., leads), is a patient condition that develops over time in some populations.The mechanism of calcification is assumed to be associated with cell devitalization and accumulation of cellular debris following implantation.Past experience has shown that as calcified material builds up on the electrode surfaces of a lead, impedance measurements increase.
Event or Problem Description
It was reported that this right ventricular (rv) defibrillation lead was suspected of lead fracture, per lead testing.However, the location of the lead fracture was not determined.Subsequently, this rv lead was explanted, replaced, and returned for analysis.It was noted that the crt-d was also explanted and replaced, with no reported allegations.No additional adverse patient effects were reported.

• 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: 21361559
• Report Number: 2124215-2025-07709
• Device Sequence Number: 8416693
• Product Code: LWS
• UDI-Device Identifier: 00802526373374
• UDI-Public: (01)00802526373374(17)150924(21)104105
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P910073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2025

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: 09/24/2015
• Device Model Number: 0171
• Device Catalogue Number: 0171
• Device Lot Number: 104105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2025
• Supplement Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2013
• 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: Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female