FDA Adverse Event
Malfunction
Summary report: N
PULSE GENERATOR, PERMANENT, IMPLANTABLE
MDR report key: 17530127
·
Received August 12, 2023
Report
- Report Number
- MW5137047
- Event Type
- Malfunction
- Date Received
- August 12, 2023
- Report Date
- September 1, 2011
- Manufacturer
- ST. JUDE MEDICAL
- Product Code
- NVZ
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
THE PHYSICIAN NOTICED WHEN CHANGING THE DEVICE OUT ON (B)(6) 2011. THERE WAS A SMALL INSULATION BREAK ON THE LEAD. HE ELECTED TO USE A LEAD REPAIR KIT TO PREVENT NAY FURTURE ISSUES WITH LEAD. NO PHYSICIAN OR HOSPITAL KNOWN. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1073990 | PULSE GENERATOR, PERMANENT, IMPLANTABLE | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | ST. JUDE MEDICAL | 1688T |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |