FDA Adverse Event
Malfunction
Summary report: N
PERMANENT PACEMAKER ELECTRODE
MDR report key: 17519287
·
Received August 12, 2023
Report
- Report Number
- MW5126235
- Event Type
- Malfunction
- Date Received
- August 12, 2023
- Report Date
- February 2, 2012
- Manufacturer
- ST. JUDE MEDICAL
- Product Code
- DTB
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
TECHNICAL SERVICES RECEIVED A CALL ON 01/16/2012 FROM SALES REP. THERE WAS NOISE SEEN ON THE RV 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 |
|---|---|---|---|---|---|---|---|
| 2244254 | PERMANENT PACEMAKER ELECTRODE | PERMANENT PACEMAKER ELECTRODE | DTB | ST. JUDE MEDICAL | 138BTC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |