MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RELIANCE 4-FRONT; PERMANENT DEFIBRILLATION ELECTRODE

Model Number 0672

Device Problems Failure to Capture (1081); Mechanical Problem (1384); Pacing Problem (1439); High Capture Threshold (3266)

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

Event Date 02/04/2024

Event Type  Injury  

Manufacturer Narrative

The product is expected to be returned for analysis.This report will be updated upon return and completion of analysis.

Event Description

It was reported that the patient implanted with this right ventricular (rv) lead presented for a routine follow up.Device interrogation found the rv pacing threshold measurements had increased; the pacing output was increased to 7.5v but there was still no capture and no pacing was delivered to the patient.Under fluoroscopy, it was confirmed the lead was not dislodged.It was noted that the r-wave, pacing impedance, and shock impedance measurements were all within normal limits.A lead revision was performed the following day.During the revision, the lead was disconnected from the device and it was observed that the helix could not be retracted.It was suspected that there was tissue stuck in the helix, and with extra effort, the helix was finally able to be retracted.The lead was repositioned, but then the helix could not be extended.Therefore, this lead was explanted and a new lead of the same model was implanted, with all parameters within an acceptable range.No additional adverse patient effects were reported.The explanted lead was expected to be returned for analysis.

• Brand Name: RELIANCE 4-FRONT
• Type of Device: PERMANENT DEFIBRILLATION ELECTRODE
• 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: 18789494
• MDR Text Key: 336396274
• Report Number: 2124215-2024-11620
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): Y
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/27/2024

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 Model Number: 0672
• Device Catalogue Number: 0672
• Device Lot Number: 217250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/04/2024
• Initial Date FDA Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male