FDA Adverse Event
Malfunction
Summary report: N
RESTORE ULTRA
MDR report key: 1193441
·
Received October 7, 2008
Report
- Report Number
- 3004209178-2008-06409
- Event Type
- Malfunction
- Date Received
- October 7, 2008
- Date of Event
- September 1, 2008
- Report Date
- September 10, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT EXPERIENCED A STRONG JERKING MOVEMENT WHILE IN BED. SINCE THEN, THE PATIENT HAS HAD NO THERAPEUTIC EFFECT. THE PATIENT HAD REPROGRAMMING OF THE SYSTEM WITH GOOD BENEFIT. ADDITIONAL INFORMATION INDICATED THE PATIENT'S LEADS HAD MIGRATED. NO FURTHER 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 | 39 YR | Required Intervention | LEAD: MODEL 3887| EXPLANTED:| EXTENSION: MODEL 37081| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3887| EXPLANTED:| LEAD: MODEL 3778| EXPLANTED:| EXTENSION: MODEL 37082 |