FDA Adverse Event
Injury
Summary report: N
KINETRA
MDR report key: 3396173
·
Received October 9, 2013
Report
- Report Number
- 3004209178-2013-17691
- Event Type
- Injury
- Date Received
- October 9, 2013
- Report Date
- September 18, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- MRU
- PMA / PMN Number
- H020007
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID: 3387S-40, LOT# V044062, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A51, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT# V023993, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A51, SERIAL# (B)(4),PRODUCT TYPE: EXTENSION. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD AN ISSUE WITH INFECTION FROM A PREVIOUS IMPLANT THAT WAS REMOVED SEVERAL YEARS PRIOR TO THE REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 512578 | KINETRA | IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) | MRU | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 7428 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00053 YR | Required Intervention |