FDA Adverse Event
Malfunction
Summary report: N
SOLETRA
MDR report key: 2012262
·
Received February 2, 2011
Report
- Report Number
- 3004209178-2011-00831
- Event Type
- Malfunction
- Date Received
- February 2, 2011
- Date of Event
- January 1, 2011
- Report Date
- January 18, 2011
- 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
- VT, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE DEEP BRAIN STIMULATOR WAS TURNING OFF INTERMITTENTLY. THE PATIENT WOULD USE HIS PATIENT PROGRAMMER TO TURN THE DEVICE BACK ON. THE PATIENT SLEPT ON AN ADJUSTABLE BED. BATTERY LIFE DID NOT APPEAR TO BE A FACTOR. REFERENCE MFG. REPORT # 3004209178-2011-00833. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION 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 | 48 YR | EXPLANTED:| EXPLANTED:| LOT# NFW157713H| EXPLANTED:| EXTENSION: MODEL 7482, LOT# NHU063673V| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7426,| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482, LOT# NHU063674V| LEAD: MODEL 3387, LOT# J0443821V| LEAD: MODEL 3387, LOT# J0443881V| EXPLANTED:| IMPLANTED: |