FDA Adverse Event
Malfunction
Summary report: N
ACTIVA
MDR report key: 4291261
·
Received December 2, 2014
Report
- Report Number
- 3004209178-2014-22395
- Event Type
- Malfunction
- Date Received
- December 2, 2014
- Date of Event
- July 18, 2014
- Report Date
- July 19, 2014
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT: PRODUCT ID 3387S-40, LOT# V014246, IMPLANTED: 2007-(B)(6), PRODUCT TYPE LEAD. PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: 2007-(B)(6), PRODUCT TYPE EXTENSION. (B)(4)
Description of Event or Problem · 1
IT WAS REPORTED THERE WERE HIGH IMPEDANCES ON SEVERAL ELECTRODE PAIRS FOR THE LEFT HEMISPHERE. NO INTERVENTIONS OR OUTCOME WERE NOTED. ADDITIONAL FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 778943 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37612 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00062 YR |