FDA Adverse Event
Malfunction
Summary report: N
RESTORE ULTRA
MDR report key: 2244048
·
Received August 24, 2011
Report
- Report Number
- 3004209178-2011-06762
- Event Type
- Malfunction
- Date Received
- August 24, 2011
- Date of Event
- August 3, 2011
- Report Date
- August 8, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- 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
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INTERMITTENT STIMULATION. THERE WERE NO FALLS OR TRAUMA TO THE AREA REPORTED. IMPEDANCE READINGS WERE GREATER THAN 40,000 OHMS WITH ELECTRODE 2 AND 3. IT WAS LATER REPORTED THAT THE PATIENT WAS REPROGRAMMED AND THE PATIENT RECEIVED GOOD STIMULATION. NO FURTHER INTERVENTION WAS PERFORMED, PER THE PATIENT'S REQUEST, AS THE AREA OF STIMULATION WAS ADEQUATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE ULTRA | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 37712 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | ACCESSORY: MODEL 37752, LOT# NKA119274N| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE124915N| EXPLANTED:| EXTENSION: MODEL 37083, LOT# NKC011290N| IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3987A, LOT# UNKNOWN| EXPLANTED:| LEAD: MODEL 3987A, LOT# UNKNOWN |