FDA Adverse Event
Injury
Summary report: N
ACTIVA
MDR report key: 2893567
·
Received January 2, 2013
Report
- Report Number
- 3004209178-2013-00060
- Event Type
- Injury
- Date Received
- January 2, 2013
- Report Date
- December 11, 2012
- 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
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT# V971421, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT# V964030, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT'S SYSTEM WAS REMOVED DUE TO INFECTION. NO FURTHER INFORMATION WAS REPORTED. 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 |
|---|---|---|---|---|---|---|---|
| 736 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37601 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |