FDA Adverse Event
Malfunction
Summary report: N
PERMANENT PACEMAKER ELECTRODE
MDR report key: 17521314
·
Received August 12, 2023
Report
- Report Number
- MW5128262
- Event Type
- Malfunction
- Date Received
- August 12, 2023
- Report Date
- June 3, 2011
- Manufacturer
- MEDTRONIC
- Product Code
- DTB
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
A CALL TO TECHNICAL SERVICES ON 05/05/2011 STATES THAT PATIENT HAS RIGHT SIDED UPPER EXTREMITY DVT. MD DID NOT WANT TO EXPLANT PACEMAKER VEDR01 WHICH WAS IMPLANTED IN 2007. PLACED LEFT SIDED SINGLE CHAMBER DEVICE. DID TESTING AT LEAST WITH PACEMAKER AT MAX OUTPUT ASYNCHRONOUS PACING, PERFORMED INDUCTION. DFT 21 J NO ISSUES. ICD PROGRAMMED VVI 40 VT MO AND VF ZONE PATIENT WITH HISTORY OF SCD AND 3 DEGREE AVD. COMMENTS NOTED MD LNRA BURKE. VERFIED VEDR01 WAS ICD COMPATITBLE. REP STATED THAT HE TURNED LEAD MONITOR OFF SO THAT THE PACEMAKER CANNOT SWITCH TO UNIPOLAR POLARITY. 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 |
|---|---|---|---|---|---|---|---|
| 2117748 | PERMANENT PACEMAKER ELECTRODE | PERMANENT PACEMAKER ELECTRODE | DTB | MEDTRONIC | VEDR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |