FDA Adverse Event
Injury
Summary report: N
KINETRA
MDR report key: 2181404
·
Received July 21, 2011
Report
- Report Number
- 3004209178-2011-05638
- Event Type
- Injury
- Date Received
- July 21, 2011
- Report Date
- June 27, 2011
- Manufacturer
- MEDTRONIC 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
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS NOT RECEIVING GOOD THERAPEUTIC EFFECTS AND WAS HAVING DIFFICULTY WALKING EVEN AFTER SEVERAL ATTEMPTS AT REPROGRAMMING. 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 | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 7428 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |