FDA Adverse Event
Malfunction
Summary report: N
ITREL 3
MDR report key: 791018
·
Received November 21, 2006
Report
- Report Number
- 6000032-2006-02007
- Event Type
- Malfunction
- Date Received
- November 21, 2006
- Report Date
- October 25, 2006
- Manufacturer
- MEL REL, INC.
- Product Code
- GZB
- PMA / PMN Number
- p840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
10/25/2006, THE PT REPORTS THEIR STIMULATION DEVICE TURNS ON WHEN GOING THROUGH SECURITY DEVICES. THE PT CONTACTED THE MANUFACTURER, EXPERIENCING PROBLEMS WITH GETTING THE PT PROGRAMMER TO TURN ON/OFF. AFTER ACHIEVING PROPER PLACEMENT OF THE PROGRAMMER THE DEVICE WAS WORKING AND THE PT WAS ABLE TO USE IT SUCCESSFULLY, HOWEVER, WAS STILL GETTING ONLY POSITIONAL STIMULATION EVEN AT HIGHEST AMPLITUDE. THE PT STATED THEIR DEVICE TURNS ON WHEN GOING THROUGH SECURITY DEVICES. NO INJURIES WERE REPORTED. THE MANUFACTURER HAS BEEN UNABLE TO CONTACT THE HCP AS OF THE DATE OF THIS REPORT. A FOLLOW UP REPORT WILL BE SENT IF ADD'L INFO IS REC'D.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ITREL 3 | LGW | GZB | MEL REL, INC. | 7425 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Other | LEAD MODEL 3986ILC LOT#N26059| IMPLANTED| EXPLANTED| IMPLANTED| EXTENSION MODEL 7495 LOT#XR0003770V| EXPLANTED. |