FDA Adverse Event
Malfunction
Summary report: N
SOLETRA
MDR report key: 1350339
·
Received December 23, 2008
Report
- Report Number
- 6000032-2008-08540
- Event Type
- Malfunction
- Date Received
- December 23, 2008
- Date of Event
- January 29, 2008
- Report Date
- December 1, 2008
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO, MED REL
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE PT'S BILATERAL STIMULATORS WERE IMPLANTED ONLY THREE INCHES APART AND SOME PROGRAMMING CROSSTALK HAD OCCURRED DUE TO THIS (REFER TO MEDWATCH REPORT# 6000032-2008-08542). IT WAS REPORTED THE PT'S STIMULATORS WERE REPLACED. THE REASON FOR REPLACEMENT WAS NOT PROVIDED. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOLETRA | MHY | MDT PUERTO RICO OPERATIONS CO, MED REL | 7426 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention | LOT# NFW117016H| IMPLANTABLE NEURO STIMULATOR: MODEL 7426| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3389| IMPLANTED:| LEAD: MODEL 3389| IMPLANTED: |