FDA Adverse Event
Malfunction
Summary report: N
SOLETRA
MDR report key: 2191981
·
Received July 22, 2011
Report
- Report Number
- 3004209178-2011-05658
- Event Type
- Malfunction
- Date Received
- July 22, 2011
- Date of Event
- April 1, 2011
- Report Date
- May 19, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THIS REPORT IS BEING SUBMITTED LATE DUE TO A DELAY BY AN MFR EMPLOYEE. TRAINING IS IN PLACE.
Description of Event or Problem · 1
IT WAS REPORTED THAT STIMULATION WAS TURNING OFF INTERMITTENTLY ON ONE SIDE DURING THE NIGHT. ADDITIONAL INFO HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. REFER TO MFR REPORT # 3004209178-2011-05659.
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 | 54 YR | IMPLANTED:| EXTENSION: MODEL 7482, LOT# NHU036267V| IMPLANTED:| EXPLANTED:| LOT# NFW152505H| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7482, LOT# NHU036284V| EXPLANTED:| PROGRAMMER: MODEL 7438, LOT# NHL009706P| IMPLANTABLE NEURO STIMULATOR: MODEL 7426,| IMPLANTED:| LEAD: MODEL 3387, LOT# J0348833V| EXPLANTED:| LEAD: MODEL 3389S, LOT# V435220| EXPLANTED: |