MAUDE Adverse Event Report: ST. JUDE MEDICAL/ABBOTT MEDICAL LEAD; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

Model Number 1056T

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

It was reported that this lead was surgically abandoned due to probe displacement.No additional 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: LEAD
• Type of Device: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL/ABBOTT MEDICAL
• MDR Report Key: 17692805
• MDR Text Key: 322832634
• Report Number: MW5145245
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1056T
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1