FDA Adverse Event
Injury
Summary report: N
RESTORE RECHARGEABLE NEUROSTIMULATOR
MDR report key: 1833184
·
Received September 9, 2010
Report
- Report Number
- 3004209178-2010-06914
- Event Type
- Injury
- Date Received
- September 9, 2010
- Date of Event
- May 1, 2010
- Report Date
- June 30, 2010
- 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
- ND, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
THE PT WAS VERY THIN. THE IMPLANTABLE NEUROSTIMULATOR RUBBED AGAINST THE PT'S RIBS, CAUSING PAIN. IT WAS DECIDED TO REPLACE THE DEVICE WITH A SMALLER DEVICE AND REPOSITION THE LEAD TO PROVIDE BETTER COVERAGE. DURING SURGERY, THE HCP REMOVED THE SET SCREW IN THE CONNECTOR BLOCK OF THE STIMULATOR, BUT WAS UNABLE TO REMOVE THE EXTENSION. THE LEAD WAS UNABLE TO BE MOVED. THE LEAD WAS ABLE TO BE REPOSITIONED. THE PT RECOVERED FROM SURGERY AND WAS HAPPY WITH THE RESULTS.
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 | 35 YR | Required Intervention | EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3892, LOT# V001835| EXPLANTED:| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3892, LOT# V001526| IMPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 37083, LOT# NKC006008N| EXTENSION: MODEL 37083, LOT# NKC006007N| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA022516N| PROGRAMMER: MODEL 37742, LOT# NJD030251N |