FDA Adverse Event
Injury
Summary report: N
RESTORE ULTRA
MDR report key: 1243715
·
Received November 25, 2008
Report
- Report Number
- 3004209178-2008-07757
- Event Type
- Injury
- Date Received
- November 25, 2008
- Date of Event
- October 1, 2008
- Report Date
- October 27, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED, THE PATIENT HAD SWELLING IN BOTH LEGS AS WELL AS SEVERE PAIN IN RIGHT LEG, ONE WEEK POST IMPLANT. SHE ALSO STATED HER RIGHT LEG SEEMED TO "JERK" ALL THE TIME. THE PATIENT HAD ATTEMPTED TO ADJUST THE STIMULATION RESULTING IN STIMULATION IN THE WRONG LOCATION AND WAS NOT HELPING WITH THE PAIN. NO OUTCOME WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION 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 | 79 YR | Required Intervention | PROGRAMMER: MODEL 37743| LEAD: MODEL 3778| ACCESSORY: MODEL 37752| EXPLANTED: |