FDA Adverse Event
Injury
Summary report: N
KINETRA
MDR report key: 2851686
·
Received November 29, 2012
Report
- Report Number
- 3004209178-2012-10962
- Event Type
- Injury
- Date Received
- November 29, 2012
- Report Date
- November 2, 2012
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), PRODUCT TYPE EXTENSION, PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), PRODUCT TYPE EXTENSION, PRODUCT ID 3387-40, LOT# J0546401V, PRODUCT TYPE LEAD, PRODUCT ID 3387-40, LOT# J0546401V, PRODUCT TYPE LEAD. (B)(4).
Description of Event or Problem · 1
ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT'S SYSTEM WAS COMPLETELY REMOVED DUE TO INFECTION. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
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 |