FDA Adverse Event
Malfunction
Summary report: N
RESTORE RECHARGEABLE NEUROSTIMULATOR
MDR report key: 2040879
·
Received March 18, 2011
Report
- Report Number
- 3004209178-2011-02098
- Event Type
- Malfunction
- Date Received
- March 18, 2011
- Date of Event
- February 1, 2011
- Report Date
- March 6, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT WALKED A HALF-MARATHON. AFTERWARD SHE EXPERIENCED LACK OF EFFECT AND FELT NO STIMULATION SENSATION. THE PT WAS ABLE TO INCREASE AND DECREASE THERAPY AMPLITUDE USING THE PT PROGRAMMER, BUT DIDN'T FEEL ANYTHING. THE IMPLANTABLE NEUROSTIMULATOR REQUIRED MORE CHARGING SINCE THE HALF MARATHON. THE FIELD REP WAS NOTIFIED OF THE EVENT. THE PT WAS IN CONTACT WITH HER HCP. ADD'L INFO HAS BEEN REQUESTED. A F/U REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE RECHARGEABLE NEUROSTIMULATOR | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37711 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | LEAD: MODEL 377745, LOT# N0045559| PROGRAMMER: MODEL 37742, LOT# NJD010190N| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB004475N| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3777, LOT# J0546821V| EXTENSION: MODEL 37081, LOT# NJB004653N |