FDA Adverse Event
Malfunction
Summary report: N
ACTIVA
MDR report key: 5294635
·
Received December 14, 2015
Report
- Report Number
- 6000153-2015-00492
- Event Type
- Malfunction
- Date Received
- December 14, 2015
- Report Date
- December 7, 2015
- Manufacturer
- NEURO - VILLALBA
- 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 MEDICAL PRODUCTS: PRODUCT ID: 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: EXTENSION. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387-40, LOT# V003964, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_BURRHOLE RING, PRODUCT TYPE: ACCESSORY. (B)(4).
Description of Event or Problem · 1
DEVICE WAS RETURNED WITH NO INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 824307 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | NEURO - VILLALBA | 3387-40 | V002854 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |