FDA Adverse Event
Malfunction
Summary report: N
RESTORE ULTRA
MDR report key: 2161098
·
Received June 17, 2011
Report
- Report Number
- 3004209178-2011-04563
- Event Type
- Malfunction
- Date Received
- June 17, 2011
- Date of Event
- June 1, 2011
- Report Date
- June 12, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT NOTED A POWER ON REST (POR) CONDITION. THE PATIENT TRIED TO RECHARGE AND PLANNED TO WORK WITH THE MANUFACTURER'S REPRESENTATIVE IF RECHARGING WAS NOT SUCCESSFUL.
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 | 48 YR | ACCESSORY: MODEL 37752, LOT# NKA148035N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 39565-65, LOT# V538659010| PROGRAMMER: MODEL 37743, LOT# NKE159018N |