FDA Adverse Event
Injury
Summary report: N
RESTORE ADVANCED RECHARGEABLE
MDR report key: 1180195
·
Received September 29, 2008
Report
- Report Number
- 3004209178-2008-06194
- Event Type
- Injury
- Date Received
- September 29, 2008
- Date of Event
- September 3, 2008
- Report Date
- September 3, 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
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE: UNABLE TO RECHARGE.
Description of Event or Problem · 1
THE PT WAS UNABLE TO RECHARGE HER IMPLANTABLE NEUROSTIMULATOR AND EXPERIENCED A LOSS OF STIMULATION SENSATION. THE PT WAS USUALLY ABLE TO GET 8 RECHARGE EFFICIENCY BARS. THE PHYSICIAN PROGRAMMER INDICATED THAT THE DEVICE WAS DISCHARGED. THE HCP ATTEMPTED TO RECHARGE HER DEVICE WITH A SECOND RECHARGER AND WAS UNABLE TO DO SO. IT WAS DETERMINED THAT THE NEUROSTIMULATOR HAD FLIPPED. THE DEVICE WAS SURGICALLY REPOSITIONED AND RETURNED. THERE WAS NO RECHARGING DIFFICULTIES AFTER SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE ADVANCED RECHARGEABLE | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 37713 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | EXPLANTED| LEAD MODEL 3778 LOT# V057641005| PROGRAMMER MODEL 37742 LOT# NJD054996N| IMPLANTED| EXPLANTED| LEAD MODEL 3778 LOT# V053947032| EXPLANTED| IMPLANTED| EXPLANTED| IMPLANTED| LOT #: NJD054996N| ACCESSORY MODEL 37752 LOT# NKA111450N| IMPLANTED |