FDA Adverse Event
Malfunction
Summary report: N
SOLETRA
MDR report key: 2152277
·
Received June 23, 2011
Report
- Report Number
- 3007566237-2011-04684
- Event Type
- Malfunction
- Date Received
- June 23, 2011
- Report Date
- May 25, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IMPEDANCE MEASUREMENTS OF >2000 OHMS WERE REPORTED ON SOME OF THE PATIENT'S UNIPOLAR ELECTRODE PAIRS. UNABLE TO FOLLOW-UP WITH THE CONTACT INFORMATION PROVIDED, HENCE NO ADDITIONAL INFORMATION WAS OBTAINED. IF ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW UP REPORT WILL BE SENT. FURTHER FOLLOW-UP WAS LIMITED DUE TO LIMITED CALLER INFORMATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, REPORT WILL BE UPDATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOLETRA | MHY | MEDTRONIC NEUROMODULATION | 7426 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | IMPLANTED:| UNKNOWN CONVERSION TYPE: MODEL LEADN, LOT# UNK| EXPLANTED: |