FDA Adverse Event
Injury
Summary report: N
KINETRA
MDR report key: 2801272
·
Received October 23, 2012
Report
- Report Number
- 3007566237-2012-02496
- Event Type
- Injury
- Date Received
- October 23, 2012
- Report Date
- September 24, 2012
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD UNDERWENT A "REPOSITIONING SURGERY" FOR HIS LEFT SIDE IMPLANTABLE NEUROSTIMULATOR (INS) IN (B)(6) 2011. IT WAS NOTED THAT THE PATIENT HAD SOME IMPROVEMENT IN HIS SYMPTOMS, BUT WAS EXPERIENCING MIXED RESULTS. IT WAS FURTHER NOTED THAT THE PATIENT HAD NOT "FOUND PROGRAMMING CHANGES THAT HAVE A SATISFACTORY BALANCE." THE PATIENT OUTCOME WAS NOT PROVIDED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KINETRA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC NEUROMODULATION | 7428 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |