FDA Adverse Event
Malfunction
Summary report: N
EXTERNAL PT RECHARGER SYSTEM
MDR report key: 1022840
·
Received March 28, 2008
Report
- Report Number
- 2182207-2008-01639
- Event Type
- Malfunction
- Date Received
- March 28, 2008
- Date of Event
- February 1, 2008
- Report Date
- February 29, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT'S IMPLANTABLE NEUROSTIMULATOR WAS OVER DISCHARGED. THE PHYSICIAN MODE WAS ENABLED TO BEGIN RECHARGING. THE PT WAS GIVEN INSTRUCTIONS ON HOW TO DO THE PHYSICIAN MODE RECHARGE AT HOME, BECAUSE THEY WERE UNABLE TO GET ENOUGH OF A CHARGE IN THE OFFICE. THE PT WAS BROUGHT BACK THE FOLLOWING WEEK FOR ANOTHER APPOINTMENT. THE NEUROSTIMULATOR WAS RECHARGING A BIT. THE PT WAS INSTRUCTED TO GO HOME AND FULLY CHARGE THE NEUROSTIMULATOR. THE PT WAS BROUGHT BACK IN THE NEXT DAY AND THE NEUROSTIMULATOR WAS RESET. THE PT WAS REMINDED OF THE IMPORTANCE OF RECHARGING TO AVOID POTENTIAL DAMAGE TO THE NEUROSTIMULATOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXTERNAL PT RECHARGER SYSTEM | LGW | MEDTRONIC NEUROMODULATION | 37752 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | IMPLANTED| IMPLANTED| EXPLANTED| IMPLANTED| EXTENSION MODEL 37083 LOT#NKC003744N| IMPLANTED| LEAD MODEL 3487A LOT#L20517| NEUROSTIMULATOR MODEL 37711| EXPLANTED| PROGRAMMER MODEL 37742 LOT#NJD033527N| EXPLANTED| EXPLANTED |