FDA Adverse Event
Malfunction
Summary report: N
DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
MDR report key: 17519277
·
Received August 12, 2023
Report
- Report Number
- MW5126225
- Event Type
- Malfunction
- Date Received
- August 12, 2023
- Report Date
- June 3, 2011
- Manufacturer
- MEDTRONIC
- Product Code
- NVN
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
THIS PATIENT HAD A HEMATOMA AND TAPE BURNS ON HIS INCISION. THIS WAS REPORTED TO MEDICAL RECORDS ON 04/25/2011. THE PATIENT WAS GIVEN ANTIBIOTICS AND WAS HEALED BY (B)(6) 2011. 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 |
|---|---|---|---|---|---|---|---|
| 2176779 | DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE | DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE | NVN | MEDTRONIC | 5076 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |