FDA Adverse Event
Injury
Summary report: N
RESTORE ADVANCED RECHARGEABLE
MDR report key: 1843593
·
Received September 22, 2010
Report
- Report Number
- 3007566237-2010-07182
- Event Type
- Injury
- Date Received
- September 22, 2010
- Report Date
- August 22, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WERE COUPLING ISSUES. THE PT WAS IMPLANTED (B)(6), 2010, AND HAD NO COUPLING BARS DARKENED IN. THE DEVICE MIGHT HAVE FLIPPED OR TILTED. BOTH THE PT PROGRAMMER AND PHYSICIAN PROGRAMMER COULD COMMUNICATE FINE WITH THE DEVICE. THE DEVICE WAS SUPERFICIAL AND COULD BE TILTED BASED ON PALPATION. ON (B)(6) 2010, COULD NOT GET COUPLING FOLLOWING IMPLANTATION. X-RAYS WERE TAKEN AND THE DEVICE WAS FLIPPED OVER. ON (B)(6) 2010, THE DOCTOR FLIPPED THE INS BACK TO THE CORRECT POSITION WITH THE POSITIONING CONFIRMED. THE BATTERY WAS SUTURED TO THE FASCIA. POST-OPERATIVELY, THE PT WAS ABLE TO CHARGE WITH 8 COUPLING BARS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE ADVANCED RECHARGEABLE | LGW | MEDTRONIC NEUROMODULATION | 37713 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |