FDA Adverse Event
Malfunction
Summary report: N
RESTORE ULTRA
MDR report key: 1800046
·
Received August 12, 2010
Report
- Report Number
- 3004209178-2010-06078
- Event Type
- Malfunction
- Date Received
- August 12, 2010
- Date of Event
- July 14, 2010
- Report Date
- July 14, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT NORMALLY FELT STIMULATION AT AN AMPLITUDE SETTING OF 4.8 VOLTS. THE PT FULLY RECHARGED THE IMPLANTABLE NEUROSTIMULATOR AND STIMULATION THERAPY WAS TURNED UP TO 6.0 VOLTS. THE PT FELT NO STIMULATION. THE AMPLITUDE WAS INCREASED TO 7 VOLTS; THE PT CONTINUED TO FEEL NO STIMULATION. THERE WAS NO KNOWN INCIDENT RELATED TO THE EVENT. ADDITIONAL INFO HAS BEEN REQUESTED. 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 | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37712 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | EXTENSION: MODEL 37083, LOT# NKC001814N| IMPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE136297N| EXPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA128128N| LEAD: MODEL 3891, LOT# J0327225V| EXPLANTED:| STIM ACCESSORY: MODEL 3550-29, LOT# N185793| EXPLANTED:| EXTENSION: MODEL 37083, LOT# NKC001811N| EXPLANTED:| IMPLANTED:| IMPLANTED: |