FDA Adverse Event
Injury
Summary report: N
RESTORE ULTRA
MDR report key: 2052648
·
Received April 7, 2011
Report
- Report Number
- 3004209178-2011-02669
- Event Type
- Injury
- Date Received
- April 7, 2011
- Date of Event
- January 1, 2011
- Report Date
- March 22, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, 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 REPLACED DUE TO MULTIPLE OVERDISCHARGES. IT WAS STATED THAT THE PT'S FAILURE TO CHARGE THE DEVICE DUE TO "A LOT OF THINGS GOING ON IN THEIR LIFE" WAS THE CAUSE OF THE OVERDISCHARGES. THE PT WAS NOT RECEIVING STIMULATION. THE DEVICE COULD NOT BE RECOVERED. AFTER REPLACEMENT, IT WAS REPORTED THE PT WAS RECEIVING ADEQUATE STIMULATION AND WAS "DOING GOOD."
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 | Required Intervention | EXPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA117369N| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE114219N| LEAD: MODEL 3777, LOT# V063639003| EXPLANTED:| IMPLANTED: |