FDA Adverse Event
Malfunction
Summary report: N
SOLETRA
MDR report key: 1934196
·
Received December 8, 2010
Report
- Report Number
- 3004209178-2010-10314
- Event Type
- Malfunction
- Date Received
- December 8, 2010
- Date of Event
- April 5, 2010
- Report Date
- November 29, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PRODUCT WAS RETURNED WITH NO INFO. ADD'L INFO RECEIVED REPORTED THAT THE STIMULATORS WERE REPLACED DUE TO DEAD BATTERIES. THIS WAS CONFIRMED THROUGH DEVICE INTERROGATION. THE PT'S STIMULATORS WERE REPLACED. THE PT WAS SEEN AFTER THE REPLACEMENT, BUT AFTER THAT THE DOCTOR HAD NOT FOLLOWED UP WITH THE PT.
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 | 72 YR | EXTENSION: MODEL 7482, LOT# NHU073563V| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 7438, LOT# NHL012615P| EXPLANTED:| LEAD: MODEL 3389, LOT# J0454940V| IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482, LOT# NHU076439V| IMPLANTED:| LEAD: MODEL 3389, LOT# J0454360V| IMPLANTED:| LOT# NFW124039H| IMPLANTABLE NEURO STIMULATOR: MODEL 7426| EXPLANTED: |