FDA Adverse Event
Malfunction
Summary report: N
ACTIVA PC
MDR report key: 1951985
·
Received January 4, 2011
Report
- Report Number
- 3004209178-2011-00019
- Event Type
- Malfunction
- Date Received
- January 4, 2011
- Date of Event
- December 1, 2010
- Report Date
- December 16, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT EXPERIENCED SUDDEN LOSS OF THERAPEUTIC EFFECT. DEEP BRAIN STIMULATOR INTERROGATION REVEALED HIGH IMPEDANCES ON 3 OF THE 4 AVAILABLE ELECTRODES. ADDITIONAL INFO HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACTIVA PC | MHY | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37601 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37085, LOT# NKN012996V| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3389S-40, LOT# V568830| PROGRAMMER: MODEL, 37642 LOT# NJZ104909N| EXPLANTED:| LEAD: MODEL 3389, LOT# V388252| EXTENSION: MODEL 37085, LOT# NKN006238V| IMPLANTED: |