MAUDE Adverse Event Report: UNKNOWN PACING LEAD; ELECTRODE, PACEMAKER, TEMPORARY

Model Number UNKNOWN

Device Problem Low impedance (2285)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that this lead has chronically shown low pacing impedance values out of range.Reportedly, the non-boston scientific pacemaker was replaced with a boston scientific device, and after the device replacement, a lead safety switch (lss) occurred.Boston scientific technical services (ts) discussed programming options due to the chronic low impedance and advise to monitor the patient on latitude.The device system remains in service.No adverse patient effects were reported.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PACING LEAD
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17527370
• MDR Text Key: 321332333
• Report Number: MW5134302
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: UNKNOWN
• Patient Sequence Number: 1