FDA Adverse Event
Injury
Summary report: N
KINETRA
MDR report key: 1201517
·
Received October 17, 2008
Report
- Report Number
- 3004209178-2008-06627
- Event Type
- Injury
- Date Received
- October 17, 2008
- Date of Event
- September 1, 2008
- Report Date
- September 19, 2008
- Manufacturer
- MEDTORNIC PUERTO RICO OPERATIONS CO.
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE IMPLANTABLE NEUROSTIMULATOR AND BOTH EXTENSIONS WERE RETURNED WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.
Description of Event or Problem · 1
THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR AND BOTH EXTENSIONS WERE REMOVED, DUE TO AN INFECTION. THE PATIENT WAS GIVEN ANTIBIOTICS. THE PATIENT RECOVERED WITHOUT SEQUELA. THERE WAS NO PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KINETRA | MHY | MEDTORNIC PUERTO RICO OPERATIONS CO. | 7428 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | EXPLANTED:| LEAD MODEL 3389S LOT# V119981| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION MODEL 7482 LOT# NHU124846V| IMPLANTED:| EXTENSION MODEL 7482 LOT# NHU164727V| EXPLANTED:| IMPLANTED:| LEAD MODEL 3389S LOT# V119981| EXPLANTED:| PROGRAMMER MODEL PROGRAMMER LOT# UNK |