FDA Adverse Event
Malfunction
Summary report: N
ACTIVA
MDR report key: 3166254
·
Received June 12, 2013
Report
- Report Number
- 3004209178-2013-10265
- Event Type
- Malfunction
- Date Received
- June 12, 2013
- Report Date
- May 22, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID 3387-40, LOT # V001236, IMPLANTED: (B)(6) 2005, PRODUCT TYPE LEAD PRODUCT ID 748240, SERIAL # (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE EXTENSION; PRODUCT ID 37642, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD A SHORT LONGEVITY. IT WAS STATED THE REPRESENTATIVE THOUGHT THERE WAS A ¿SHORT OR OPEN¿ INVOLVED IN THAT CASE. REPORTEDLY THE ELECTIVE REPLACEMENT INDICATOR (ERI)TIME WAS 2.2 YEARS AND THE END OF SERVICE (EOS) TIME WAS 2.5 YEARS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 265281 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37602 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |