FDA Adverse Event
Injury
Summary report: N
KINETRA
MDR report key: 2854581
·
Received December 3, 2012
Report
- Report Number
- 3004209178-2012-11056
- Event Type
- Injury
- Date Received
- December 3, 2012
- Report Date
- November 5, 2012
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
PRODUCT ID, NEU_UNKNOWN_LEAD, UNKNOWN, PRODUCT TYPE LEAD PRODUCT ID, NEU_UNKNOWN_EXT, SERIAL# UNKNOWN, PRODUCT TYPE EXTENSION. (B)(4). NO DEVICE ANALYSIS WAS PERFORMED; THE DEVICE MET RISK BASED CRITERIA.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD THE DEVICE REPLACED DUE TO NORMAL BATTERY DEPLETION. THE PATIENT'S EXTENSION WAS ALSO REPORTED AS "BROKEN." THE PATIENT WAS PART OF (B)(6) STUDY. THERE WAS NO PATIENT INJURY AND THE PATIENT RECOVERED WITHOUT SEQUELA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KINETRA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 7428 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |