FDA Adverse Event
Injury
Summary report: N
KINETRA
MDR report key: 2181310
·
Received July 21, 2011
Report
- Report Number
- 3004209178-2011-05637
- Event Type
- Injury
- Date Received
- July 21, 2011
- Report Date
- June 27, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE NEUROSTIMULATOR WAS IMPLANTED IN (B)(6) 2009, AND THE PATIENT WAS NOT RECEIVING GOOD THERAPEUTIC EFFECTS. THE PATIENT WAS HAVING DIFFICULTY WALKING. THE DEVICE WAS EXPLANTED AND REPLACED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KINETRA | MHY | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 7428 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Required Intervention | UNK. |