FDA Adverse Event
Malfunction
Summary report: N
RESTORE ULTRA
MDR report key: 2081553
·
Received April 19, 2011
Report
- Report Number
- 3004209178-2011-02906
- Event Type
- Malfunction
- Date Received
- April 19, 2011
- Date of Event
- January 1, 2011
- Report Date
- March 30, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PT'S DEVICE WAS TURNING OFF ON ITS OWN. IT WAS STATED THAT, WHEN THE BATTERY ON THE PT'S DEVICE IS "1/2 FULL, IT DOESN'T FEEL LIKE IT'S ON. ALSO WHEN THE BATTER IS 3/4 FULL IS SHUTS OFF ON ITS OWN." ADD'L INFO HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SENT IF ADD'L INFO 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 | 42 YR | IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT# V084702023| IMPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE105387N| LEAD: MODEL 3778, LOT# V078230009| ACCESSORY: MODEL 37752, LOT # NKA035583N| EXPLANTED:| EXPLANTED: |