FDA Adverse Event
Malfunction
Summary report: N
VERSA DR
MDR report key: 1863181
·
Received October 9, 2010
Report
- Report Number
- 6000144-2010-05089
- Event Type
- Malfunction
- Date Received
- October 9, 2010
- Date of Event
- July 29, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- NVZ
- PMA / PMN Number
- P980035/S043
- Removal / Correction Number
- ASKU
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD A "PAIN" IN THEIR CHEST "FELT LIKE THEY MIGHT PASS OUT". THEY ALSO REPORTED THAT THEY WERE TOLD THAT IT MIGHT BE FROM A "STAPH INFECTION A FEW YEARS AGO". THE DEVICE IS STILL IN USE. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VERSA DR | IMPLANTABLE PULSE GENERATOR | NVZ | MEDTRONIC MED REL, INC. | VEDR01 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 89 YR | Other | 5076 IMPLANTABLE PACING LEAD| 5054 IMPLANTABLE PACING LEAD |