FDA Adverse Event
Injury
Summary report: N
ACTIVA
MDR report key: 3013392
·
Received March 20, 2013
Report
- Report Number
- 3004209178-2013-03999
- Event Type
- Injury
- Date Received
- March 20, 2013
- Report Date
- March 6, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
PRODUCT ID, 7482A40 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 3387S-40 LOT# V042082, IMPLANTED: 2007 (B)(6), PRODUCT TYPE LEAD. (B)(4).
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED FROM THE HCP REPORTED THAT THE INFECTION RESOLVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT'S LEFT EXTENSION AND BATTERY WERE EXPLANTED DUE TO AN INFECTION. BOTH LEADS AND THE RIGHT EXTENSION AND BATTERY REMAINED IMPLANTED AND UNCHANGED. IT WAS NOTED THAT THE REMOVED COMPONENTS WOULD BE REPLACED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 115994 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37602 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |