FDA Adverse Event
Malfunction
Summary report: N
ITREL 3
MDR report key: 1133624
·
Received August 20, 2008
Report
- Report Number
- 3004209178-2008-05098
- Event Type
- Malfunction
- Date Received
- August 20, 2008
- Date of Event
- July 1, 2008
- Report Date
- July 22, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT EXPERIENCED SHOCKING/JOLTING SENSATION FOLLOWING EXPOSURE TO A THEFT DETECTOR AT ANY STORE. THE DEVICE HAS BEEN ON DURING THE EXPOSURE. THE PATIENT TURNS IT DOWN A LITTLE BIT BUT DOESN'T TURN IT OFF. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HEALTH PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ITREL 3 | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 7425 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | EXPLANTED:| EXPLANTED:| IMPLANTED:| LEAD MODEL 3987 LOT# NBC001700N| IMPLANTED:| EXTENSION MODEL 7496-25 LOT# NAG001940N |