FDA Adverse Event
Malfunction
Summary report: N
RESTORE ULTRA
MDR report key: 1853886
·
Received September 7, 2010
Report
- Report Number
- 3004209178-2010-06831
- Event Type
- Malfunction
- Date Received
- September 7, 2010
- Report Date
- August 10, 2010
- 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
A POWER ON RESET CONDITION WAS REPORTED. NO FURTHER DETAILS OF THE ISSUE, OR THE PT'S STATUS/OUTCOME WERE REPORTED. ADDITIONAL INFO IS BEING REQUESTED, 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 | EXPLANTED:| EXPLANTED:| LEAD: MODEL 39565, LOT# N184552001| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE119159N| IMPLANTED:| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA123882N| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB051627V| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB051642V| IMPLANTED: |