FDA Adverse Event
Malfunction
Summary report: N
SOLETRA
MDR report key: 2021791
·
Received February 25, 2011
Report
- Report Number
- 3004209178-2011-01450
- Event Type
- Malfunction
- Date Received
- February 25, 2011
- Date of Event
- February 6, 2011
- Report Date
- February 9, 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
- PA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT WHICH STARTED 3 DAYS AGO. THE PT SEEMED TO HAVE LOST MUSCULAR CONTROL, COULD NOT SUPPORT HIMSELF (INTERMITTENT GRIP) OR BEND OVER. HIS EYES WERE CLOSED AND COULD NOT SPEAK AS LOUD AND CLEAR, HE WAS VERY TIRED, AND WAS HARD TO WAKE UP. HIS PROGRAMMER INDICATED THAT HIS NEUROSTIMULATOR WAS TURNED ON. ADD'L INFO WAS REQUESTED. SEE MFR REPORT # 3004209178-2011-01449.
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 | 77 YR | LEAD: MODEL 3389, LOT# J0454360V| EXTENSION: MODEL 7482, LOT# NHU077293V| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED: |