FDA Adverse Event
Malfunction
Summary report: N
SOLETRA
MDR report key: 1950376
·
Received December 14, 2010
Report
- Report Number
- 3004209178-2010-10464
- Event Type
- Malfunction
- Date Received
- December 14, 2010
- Report Date
- December 3, 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
- UT, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS ORIGINALLY REPORTED THAT THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE PT PROGRAMMER (PP) SEEMED TO FUNCTION NORMAL BUT IT WOULD NOT FIND THE NEUROSTIMULATOR (INS). THE PP BEEPED AND DISPLAYED THE 9V STATUS. ADDITIONAL INFORMATION RECEIVED CONFIRMED THE PT DISCUSSED THIS EVENT WITH A COMPANY REPRESENTATIVE. HIS DEVICE WAS REPROGRAMMED SUCCESSFULLY BUT STILL HAD PROBLEMS WITH HIS DEVICE SYSTEM. WHEN HE MOVED HE FELT A JOLT OF ELECTRICITY UP HIS ARM. HIS DOCTOR TURNED OFF ONE OF THE ELECTRODES AS IT HELPED CORRECT THE PROBLEM. ONCE IN A WHILE HE STILL FELT A SLIGHT BIT OF ELECTRICITY IN HIS ARM. FURTHER INFORMATION HAS BEEN REQUESTED.
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 | EXTENSION: MODEL 7495, LOT# XR0078452N| LEAD: MODEL 3387, LOT# L80495| EXPLANTED:| PROGRAMMER: MODEL 7438, LOT# NHL015014P| IMPLANTED:| EXPLANTED:| IMPLANTED: |