FDA Adverse Event
Malfunction
Summary report: N
RESTORE ULTRA
MDR report key: 2992340
·
Received March 7, 2013
Report
- Report Number
- 3004209178-2013-03425
- Event Type
- Malfunction
- Date Received
- March 7, 2013
- Date of Event
- June 30, 2012
- Report Date
- February 14, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS "IMPLANTED 474 DAYS" AFTER IT HAD EXPIRED. INFORMATION FROM THE MANUFACTURER'S DATABASES REGARDING WHETHER THE DEVICE WAS EXPLANTED WAS FOUND TO BE CONFLICTING. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 98198 | RESTORE ULTRA | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37712 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR |