FDA Adverse Event
Malfunction
Summary report: N
PULSE GENERATOR, PERMANENT, IMPLANTABLE
MDR report key: 17536168
·
Received August 12, 2023
Report
- Report Number
- MW5143058
- Event Type
- Malfunction
- Date Received
- August 12, 2023
- Report Date
- August 10, 2012
- Manufacturer
- PACESETTER
- Product Code
- NVZ
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
TECHNICAL SERVICES RECEIVED A CALL ON 07/25/2012 FROM SALES REP. THE LEAD WAS IMPLANTED ON (B)(6) 2008. PATIENT HAS A FRACTURED ATRIAL LEAD BUT CALLER DOES NOT KNOW WHEN THIS WAS FIRST NOTED OR ANYTHING RELATED TO THE ISSUE OR IF IT LEAD TO ANY ADVERSE PATIENT EFFECTS. THE PHYSICIAN WAS DR (B)(6) UNKNOWN HOSPITAL. 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 |
|---|---|---|---|---|---|---|---|
| 783997 | PULSE GENERATOR, PERMANENT, IMPLANTABLE | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | PACESETTER | 1688T |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |