FDA Adverse Event
Injury
Summary report: N
RESTORE RECHARGABLE NEUROSTIMULATOR
MDR report key: 1970125
·
Received January 14, 2011
Report
- Report Number
- 3004209178-2011-00381
- Event Type
- Injury
- Date Received
- January 14, 2011
- Date of Event
- November 25, 2010
- Report Date
- January 5, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT WOKE UP WITH PAIN AT THE NEUROSTIMULATOR SITE. THE SITE WAS RED IN A CIRCULAR PATTERN ON HER SKIN. THERE WAS A BUMP IN THE MIDDLE OF HER BACK AT THE LEAD SITE. SHE ALSO HAD STIMULATION IN THE WRONG LOCATION (RIGHT ARM, LEFT FOOT) AS A RESULT OF REPROGRAMMING SEVERAL MONTHS AGO. SHE WAS SUPPOSED TO HAVE STIMULATION TO THE LOWER BACK AND LEG FOR PAIN RELIEF. SUBSEQUENTLY, IT WAS REPORTED THAT THE PT'S LEAD WAS PROTRUDING OUT OF HER BODY AS A RESULT OF EROSION. AN INFECTION OF STAPHYLOCOCCUS (NOT MRSA) WAS ALSO CONFIRMED. THE PHYSICIAN PLANNED TO EXPLANT THE DEVICE. ADDITIONAL INFO WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE RECHARGABLE NEUROSTIMULATOR | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37711 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention | IMPLANTED:| LEAD: MODEL 3777, LOT# V182949021| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA124192N| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3777, LOT# V063639028| PROGRAMMER: MODEL 37743, LOT# NKE119899N |