FDA Adverse Event
Malfunction
Summary report: N
ITREL 3
MDR report key: 1111648
·
Received August 13, 2008
Report
- Report Number
- 3004209178-2008-04928
- Event Type
- Malfunction
- Date Received
- August 13, 2008
- Date of Event
- July 1, 2008
- Report Date
- July 17, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE PT EXPERIENCED A SHOCKING OR JOLTING SENSATION AT THE IMPLANTABLE NEUROSTIMULATOR LOCATION. THERE WAS A KNOWN ACCIDENT OR INCIDENT RELATED TO THE EVENT; THE PT WAS STANDING IN A HALLWAY. THE PT'S DEVICE WAS REPROGRAMMED AND THE PT WAS DOING OKAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ITREL 3 | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 7425 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention | IMPLANTED| EXPLANTED| EXTENSION MODEL 7495-51 LOT# XR0068057N| IMPLANTED| EXPLANTED| LEAD MODEL 3888 LOT# J0101856V |