FDA Adverse Event
Malfunction
Summary report: N
SOLETRA
MDR report key: 2150578
·
Received June 22, 2011
Report
- Report Number
- 3007566237-2011-04658
- Event Type
- Malfunction
- Date Received
- June 22, 2011
- Date of Event
- January 1, 2011
- Report Date
- May 25, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- 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
THE PT HAD GOOD LEAD PLACEMENT AND GOOD TREMOR SUPPRESSION AFTER HIS LEAD IMPLANT. HIS NEUROSTIMULATOR WAS LATER IMPLANTED AND HE VISITED HIS HEALTH CARE PROFESSIONAL (HCP) FOR PROGRAMMING. THE HCP WAS UNABLE TO CONTROL HIS TREMOR WITH STIMULATION DURING THE PROGRAMMING. A CT SCAN SHOWED THAT THE LEAD WAS PULLED BACK ABOUT 1 CM. THE HCP PLANNED TO PERFORM A REVISION AND TRY TO ADVANCE THE LEAD TO ITS CORRECT POSITION. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.
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 | EXPLANTED:| IMPLANTED:| LEAD: MODEL LEADMVD, LOT # UNKNOWN |