FDA Adverse Event
Malfunction
Summary report: N
SOLETRA
MDR report key: 2081443
·
Received April 22, 2011
Report
- Report Number
- 3004209178-2011-03037
- Event Type
- Malfunction
- Date Received
- April 22, 2011
- Date of Event
- March 30, 2011
- Report Date
- April 4, 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
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS A BENT CONTACT ON A LEAD. THE LEAD WAS NOT USED IN THE IMPLANT. ADDITIONAL INFORMATION WAS 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 | 68 YR | IMPLANTED:| EXPLANTED:| LEAD: MODEL 3389S-40, LOT# V476627| IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| MODEL 7426, LOT# NFW165314H| LEAD: MODEL 3389S-40, LOT# V616993| LEAD: MODEL 3389S-40, LOT# V436025| IMPLANTED:| EXTENSION: MODEL 7482A51, LOT# NHU210575V| IMPLANTABLE NEURO STIMULATOR:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7482A51, LOT# NHU210577V| EXPLANTED: |