FDA Adverse Event
Injury
Summary report: N
RESTORE ULTRA
MDR report key: 1060645
·
Received June 13, 2008
Report
- Report Number
- 3004209178-2008-03204
- Event Type
- Injury
- Date Received
- June 13, 2008
- Date of Event
- April 1, 2008
- Report Date
- May 15, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT SEVERAL WEEKS POST-IMPLANT, THE PATIENT'S MASTOID MUSCLE WAS VERY HARD FOLLOWING THE PATH OF LEAD. THE PT ATTEMPTED TO TURN DOWN THE STIMULATION, ALTHOUGH THE MUSCLE "STILL FELT HARD". WHEN THE STIMULATION WAS TURNED UP TO WHERE IT HAD BEEN SET AT, THE PT EXPERIENCED MORE PAIN AND STIMULATION DOWN THE LEFT ARM. THE PT WAS SEEN BY THE HCP WHO REPORTED THE "PLATISMIC" MUSCLE WAS INJECTED WITH STEROIDS AND THE PT HAD COMPLETE RELIEF OF THE SPASM AND PAIN POST INJECTION. THE PT RECOVERED WITHOUT SEQUELA. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE ULTRA | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 37712 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | PROGRAMMER MODEL 37743 LOT# NKE104214N IMPLANTED| EXTENSION MODEL 37083 LOT# NKC014937N IMPLANTED| EXPLANTED| EXPLANTED |