FDA Adverse Event
Injury
Summary report: N
KINETRA
MDR report key: 2999685
·
Received March 12, 2013
Report
- Report Number
- 3004209178-2013-03593
- Event Type
- Injury
- Date Received
- March 12, 2013
- Report Date
- February 19, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID: 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387-40, LOT# V003964, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 3387-40, LOT# V003964, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT'S DEVICE WAS TAKEN OUT AND REPLACED IN 2008, DUE TO AN INFECTION. NO FURTHER INFORMATION WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 103353 | KINETRA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 7428 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |