FDA Adverse Event
Injury
Summary report: N
RESTORE ULTRA
MDR report key: 2000261
·
Received February 17, 2011
Report
- Report Number
- 3004209178-2011-01186
- Event Type
- Injury
- Date Received
- February 17, 2011
- Date of Event
- August 1, 2010
- Report Date
- January 31, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IMPLANTABLE NEUROSTIMULATOR THERAPY STOPPED COVERING THE PT'S PAIN. MULTIPLE REPROGRAMMING EFFORTS WERE UNSUCCESSFUL IN IMPROVING COVERAGE. TWO OR THREE YEARS AFTER THE LOSS OF EFFECT, THE SYSTEM WAS EXPLANTED. THE PT HAD NO COMPLAINTS ABOUT THE HCP OR THE MFR. 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 | 53 YR | Required Intervention | IMPLANTED:| PROGRAMMER: MODEL 37743, LOT # NKE111639N| ACCESSORY: MODEL 37752, LOT # NKA115161N| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT # NJB040193V| EXPLANTED:| LEAD: MODEL 39565-30, LOT # N135879004 |