MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOTAK RELIANCE SG; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number 0292

Device Problem High impedance (1291)

Patient Problem Calcium Deposits/Calcification (1758)

Event Date 03/08/2024

Event Type  malfunction  

Manufacturer Narrative

If pertinent information is provided in the future, a supplemental report will be submitted.

Event Description

It was reported that right ventricular (rv) defibrillation lead exhibited a high out-of-range shock impedance measurement of 140 ohms.The shock impedance measurement at implant was 83 ohms, and measurements over the last year were in the 110s-120s ohms range.Evidence suggests lead calcification likely the cause of the gradually increasing shock impedance measurements over the last year.Technical services (ts) discussed troubleshooting options and programming considerations, such as performing commanded shocks.This rv lead remains in service.No adverse patient effects and no interventions were reported at this time.

• Brand Name: ENDOTAK RELIANCE SG
• Type of Device: PERMANENT DEFIBRILLATOR ELECTRODES
• 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: 18994602
• MDR Text Key: 338900545
• Report Number: 2124215-2024-18890
• Device Sequence Number: 1
• Product Code: NVY
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P910073/S077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/06/2014
• Device Model Number: 0292
• Device Catalogue Number: 0292
• Device Lot Number: 106216
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Female