FDA Adverse Event
Malfunction
Summary report: N
SOLETRA
MDR report key: 1951983
·
Received January 4, 2011
Report
- Report Number
- 3004209178-2011-00024
- Event Type
- Malfunction
- Date Received
- January 4, 2011
- Date of Event
- December 1, 2010
- Report Date
- December 17, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
A POWER SUBSTATION WAS BUILT 100-150 FEET AWAY FROM HER HOUSE. THE DEEP BRAIN STIMULATOR TURNED OFF AT LEAST TWICE. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THE COMPLAINT. REFERENCE MFG. REPORT # 3004209178-2011-0022. 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 | SOLETRA | MHY | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 7426 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | EXPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3387S, LOT# V081575| IMPLANTED:| EXTENSION: MODEL 7482, LOT# NHU041386V| EXPLANTED:| LOT# NFW161581H| IMPLANTABLE NEURO STIMULATOR: MODEL 7426| EXPLANTED:| LEAD: MODEL 3387, LOT# J0401877V| EXTENSION: MODEL 7482A51, LOT# NHU168846V| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED: |