FDA Adverse Event
Malfunction
Summary report: N
SOLETRA
MDR report key: 1926257
·
Received November 11, 2010
Report
- Report Number
- 3004209178-2010-09308
- Event Type
- Malfunction
- Date Received
- November 11, 2010
- Date of Event
- January 1, 2010
- Report Date
- October 26, 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
- NJ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT STIMULATION WS PERIODICALLY TURNING OFF ON THE RIGHT SIDE. IT WAS BELIEVED THAT THE INCIDENTS MIGHT HAVE BEEN RELATED TO THE "KINDLE" OR THE REFRIGERATOR DOOR, BUT DID NOT SEE A CORRELATION BECAUSE THE SYMPTOMS TOOK AWHILE TO PRESENT THEMSELVES. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT 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 | 63 YR | EXTENSION: MODEL 7482, LOT # NHU060402V| EXTENSION: MODEL 7482A51, LOT # NHU191188V| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3387S, LOT #V192123| IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7426,| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| LOT # NFW144747H| LEAD: MODEL 3387, LOT # J0424916V |