FDA Adverse Event
Malfunction
Summary report: N
RESTORE ULTRA
MDR report key: 1832305
·
Received September 3, 2010
Report
- Report Number
- 3004209178-2010-06779
- Event Type
- Malfunction
- Date Received
- September 3, 2010
- Date of Event
- August 9, 2010
- Report Date
- August 9, 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
- MO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
RECEIVED INFORMATION FROM THE PATIENT REPORTING A SHOCKING OR JOLTING SENSATION FOLLOWING A CHANGE OF POSITION. PATIENT WAS TALKED THROUGH ADJUSTING HIS STIMULATION WITH THE PATIENT PROGRAMMER AND THAT RESOLVED THE PROBLEM. PATIENT REQUESTED MORE TRAINING ON USING THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED A FOLLOW UP REPORT WILL BE SENT.
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 | 36 YR | PROGRAMMER: MODEL 37743, LOT# NKE130160N| STIM ACCESSORY: MODEL 3550-39, LOT#N176125| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA128001N| LEAD: MODEL 39565-65, LOT# N210262003| IMPLANTED: |