MAUDE Adverse Event Report: ST. JUDE MEDICAL/ABBOTT MEDICAL LEAD; PERMANENT PACEMAKER ELECTRODE

Model Number 1699TC

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Purulent Discharge (1812); Unspecified Infection (1930); Pocket Erosion (2013)

Event Type  Injury  

Event Description

It was reported that the leads began to erode through the pocket, antibiotic treatment was given but the wound continued to worsen, and there was purulent drainage.The implantable cardioverter defibrillator (icd) and leads were explanted.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: LEAD
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL/ABBOTT MEDICAL
• MDR Report Key: 17336307
• MDR Text Key: 319283751
• Report Number: MW5119506
• Device Sequence Number: 1
• Product Code: DTB
• 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: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1699TC
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1