FDA Adverse Event
Malfunction
Summary report: N
RESTORE ULTRA
MDR report key: 2022190
·
Received February 28, 2011
Report
- Report Number
- 3004209178-2011-01494
- Event Type
- Malfunction
- Date Received
- February 28, 2011
- Date of Event
- February 11, 2011
- Report Date
- February 11, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- 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
RECEIVED INFO THAT WHILE RECHARGING THE INS FOR A FUTURE IMPLANT PROCEDURE THE MFR'S REP NOTED A POWER ON RESET MODE APPEARED ON THE RECHARGER SCREEN. THE INS WAS ABLE TO BE RECHARGED TO 100% AND UPON INTERROGATION DISPLAYED THE ERROR CODE 0X0. REP WAS ABLE TO CLEAR THE POR AND APPEARS TO HAVE NORMAL FUNCTION RESTORED. THE DEVICE WAS RE-INTERROGATED AND NO FURTHER CODES OR MESSAGES WERE SEEN.
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 |