FDA Adverse Event
Malfunction
Summary report: N
RESTORE ULTRA
MDR report key: 1800015
·
Received August 12, 2010
Report
- Report Number
- 3004209178-2010-06053
- Event Type
- Malfunction
- Date Received
- August 12, 2010
- Date of Event
- July 1, 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
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
BOTH LEADS MIGRATED OUT OF THE EPIDURAL SPACE. THE PT WAS RECHARGING MORE THAN EXPECTED (EVERY OTHER DAY). RECHARGE STATISTICS SHOWED THAT THE PT WAS RECHARGING WITH GOOD DURATION. COUPLING WAS GENERALLY GOOD. THE IMPLANTABLE NEUROSTIMULATOR WAS TAKING THE CHARGE FINE. 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 | 55 YR | IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA121584N| EXPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE124662N| LEAD: MODEL 3778, LOT # V295360010| LEAD: MODEL 3778, LOT # V295360012 |