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

Model Number 0295

Device Problems Signal Artifact/Noise (1036); Failure to Capture (1081); Fracture (1260); Pacing Problem (1439); Under-Sensing (1661); Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/28/2024

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that after a routine follow up, this right ventricular (rv) lead exhibited loss of capture (loc), noise, undersensing and impaired pacing and sensing.It was noted this rv lead was fractured.Ultimately, this rv lead and device were explanted and replaced with a new system.No additional adverse patient effects were reported.

Manufacturer Narrative

The returned lead was analyzed.Visual inspection of the lead noted both the internal and the external insulation was abraded through to the conductor coil.Microscopic evaluation indicated that the insulation damage was caused by localized compressive stress on the insulation surface.Due to the location and the type of damage exhibited, it was concluded that the damage was caused by lead entrapment in the clavicle/first-rib region.

Event Description

It was reported that after a routine follow up, this right ventricular (rv) lead exhibited loss of capture (loc), noise, undersensing and impaired pacing and sensing.It was noted this rv lead was fractured.Ultimately, this rv lead and device were explanted and replaced with a new system.No additional adverse patient effects were reported.

• Brand Name: ENDOTAK RELIANCE G
• 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: 19088601
• MDR Text Key: 339927856
• Report Number: 2124215-2024-22127
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/31/2024

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/04/2016
• Device Model Number: 0295
• Device Catalogue Number: 0295
• Device Lot Number: 134457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/11/2024
• Supplement Dates Manufacturer Received: 10/03/2015
• Supplement Dates FDA Received: 05/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2014
• 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 Outcome(s): Required Intervention; Hospitalization
• Patient Age: 56 YR
• Patient Sex: Female