FDA Adverse Event
Malfunction
Summary report: N
ITREL 3
MDR report key: 2081549
·
Received April 19, 2011
Report
- Report Number
- 3004209178-2011-02909
- Event Type
- Malfunction
- Date Received
- April 19, 2011
- Date of Event
- March 29, 2011
- Report Date
- March 29, 2011
- 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
- UT, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENTS DEVICE TURNED ON WHILE HE WAS STANDING TOO CLOSE TO AN ELECTRONIC VIDEO GAME. THE DEVICE HAD BEEN TURNED OFF, AS THE PT PLANNED ON HAVING ORAL SURGERY. THE PT NEEDED HELP CHECKING THE DEVICE AND TURNING IT BACK OFF AGAIN. ADD'L INFO WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ITREL 3 | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 7425 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | PROGRAMMER: MODEL 7434, LOT# YN0042001P| LEAD: MODEL 3887, LOT# L79301| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7495-51, LOT# XR0045502N| EXPLANTED: |