FDA Adverse Event
Injury
Summary report: N
ACTIVA
MDR report key: 2735903
·
Received September 7, 2012
Report
- Report Number
- 3007566237-2012-02170
- Event Type
- Injury
- Date Received
- September 7, 2012
- Report Date
- August 10, 2012
- Manufacturer
- MEDTRONIC NEUROMODULATION
- 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
PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, IMPLANTED: UNK, EXPLANTED: UNK, PRODUCT TYPE LEAD PRODUCT ID NE U_UNKNOWN_EXT, SERIAL# UNKNOWN, IMPLANTED: UNK, EXPLANTED: UNK, PRODUCT TYPE EXTENSION. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) AND EXTENSION COMPONENT MAY BE EXPLANTED DUE TO AN INFECTION. THE LEAD COMPONENT WAS TO BE CAPPED IN PLACE. NO FOLLOW UP INFORMATION WAS ABLE TO BE OBTAINED. HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC NEUROMODULATION | NEU_INS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |