FDA Adverse Event
Injury
Summary report: N
SOLETRA
MDR report key: 2250731
·
Received September 12, 2011
Report
- Report Number
- 3004209178-2011-07696
- Event Type
- Injury
- Date Received
- September 12, 2011
- Date of Event
- January 1, 2011
- Report Date
- August 19, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- MHY
- PMA / PMN Number
- P960009/S7
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT'S NEUROSTIMULATOR ON THEIR LEFT SIDE (PT HAD 2 DEVICE SYSTEMS) SHUT OFF FREQUENTLY AND THAT THE EXTENSION ON THE LEFT SIDE WAS "COMING THROUGH THE SKIN". THE PT OUTCOME WAS REPORTED AS RECOVERED WITHOUT SEQUELAE. SEE ALSO MFR REPORT #3004209178201107142 FOR PREVIOUS NEUROSTIMULATOR ISSUE.
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 | 51 YR | Required Intervention | EXPLANTED:| LEAD: MODEL 3387, LOT # J0319999V| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7426| LEAD: MODEL 3387, LOT #J0319999V| EXPLANTED:| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7426| LOT #NFW133690H| EXTENSION: MODEL 7482, LOT #NHU013570V| EXPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 7438, LOT #NHL007240P| EXPLANTED:| EXTENSION: MODEL 7482, LOT #NHU014220V| LOT #NFW133689H| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED: |