FDA Adverse Event
Malfunction
Summary report: N
PERMANENT PACEMAKER ELECTRODE
MDR report key: 17524248
·
Received August 12, 2023
Report
- Report Number
- MW5131195
- Event Type
- Malfunction
- Date Received
- August 12, 2023
- Report Date
- May 4, 2011
- Manufacturer
- VITATRON
- Product Code
- DTB
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
A CALL TO TECHNICAL SERVICES ON 4/5/11 STATES THAT REP IS IN A CASE WHERE AN ATRIAL VITATRON LEAD HAD FAILED. LEAD CAPPED AND A NEW LEAD PLACED WITH GOOD RESULTS. PATIENT DID WELL. 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 |
|---|---|---|---|---|---|---|---|
| 2244578 | PERMANENT PACEMAKER ELECTRODE | PERMANENT PACEMAKER ELECTRODE | DTB | VITATRON | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |