FDA Adverse Event
Malfunction
Summary report: N
SOLETRA
MDR report key: 2211076
·
Received August 5, 2011
Report
- Report Number
- 9614453-2011-06107
- Event Type
- Malfunction
- Date Received
- August 5, 2011
- Date of Event
- July 11, 2011
- Report Date
- July 12, 2011
- Manufacturer
- MEDTRONIC EUROPE SARL
- 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 IMPEDANCES OF >2000 OHMS WERE ON SOME OF THE UNIPOLAR PAIRS. IT APPEARED LIKELY THAT BOTH 0 AND 1 WERE OPEN CIRCUITS. A LEAD FRACTURE WAS SUSPECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOLETRA | MHY | MEDTRONIC EUROPE SARL | 7426 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | EXPLANTED:| EXTENSION: MODEL 7482, LOT #NHU224607V| LEAD: MODEL 3387, LOT #0204881969| IMPLANTED:| EXPLANTED:| IMPLANTED: |