FDA Adverse Event
Malfunction
Summary report: N
RESTORE ULTRA
MDR report key: 1852076
·
Received September 28, 2010
Report
- Report Number
- 3004209178-2010-07404
- Event Type
- Malfunction
- Date Received
- September 28, 2010
- Date of Event
- August 1, 2010
- Report Date
- August 30, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DISPLAY ON THE PATIENT PROGRAMMER SHOWED THE "CALL YOUR DOCTOR" ICON. A POWER ON RESET (POR) CONDITION ALSO OCCURRED. THIS WAS BYPASSED AND THE PATIENT WAS ABLE TO RECHARGE. THE PATIENT REPORTED THE POR CONDITION AGAIN TWO DAYS LATER. IT WAS UNCLEAR IF THIS REPORT OF THE POR CONDITION WAS A NEW EVENT OR ONGOING FROM THE PREVIOUS EVENT. THE POR WAS CLEARED AND THE ISSUE WAS RESOLVED. IT WAS ALSO REPORTED THAT THE PATIENT REPORTED NEVER RECEIVED THERAPEUTIC EFFECT. NO FURTHER DETAILS, PATIENT SYMPTOMS OR OUTCOME WERE PROVIDED AT THE TIE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION 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 | 65 YR | LEAD: MODEL 3778, LOT# V416779018| LEAD: MODEL 3888, LOT# V419063| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 37082, LOT# NKB005158V| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA137775N| LEAD: MODEL 3888, LOT# V419063| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# UNK |