FDA Adverse Event
Malfunction
Summary report: N
RESTORE ULTRA
MDR report key: 1890217
·
Received October 22, 2010
Report
- Report Number
- 3004209178-2010-08295
- Event Type
- Malfunction
- Date Received
- October 22, 2010
- Date of Event
- January 1, 2010
- Report Date
- September 27, 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
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
A PT EXPERIENCED A SHOCKING/JOLTING SENSATION AT THE LOCATION OF THE IMPLANTED NEUROSTIMULATOR FOLLOWING A FALL. THE PT FELL IN JUNE. A PHYSICIAN HAD CHECKED THE PT'S DEVICE SYSTEM, AND DETERMINED THAT IT WAS WORKING FINE. THE PT HAD RECHARGED THEIR DEVICE ON (B)(6) 2010, AND THE DEVICE WAS DEPLETED TWO DAYS LATER. THE PT NORMALLY CHARGED THEIR DEVICE EVERY WEEK. THE PT'S STATUS WAS NOTED AS BEING FAIR, HOWEVER, THE PT'S OUTCOME WAS NOT REPORTED. ADD'L INFO IS BEING REQUESTED FROM THE HCP, AND WILL BE PROVIDED IN A F/U REPORT AS IT 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 | ACCESSORY: MODEL 37752, LOT# NKA 119084N| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE113100N| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 37083, LOT# NKC015654N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3986A, LOT# N179498| LEAD: MODEL 3986A, LOT# N158921| EXPLANTED:| EXTENSION: MODEL 37083, LOT# NKC016308N| EXPLANTED: |