FDA Adverse Event
Malfunction
Summary report: N
RESTORE ULTRA
MDR report key: 3013311
·
Received March 20, 2013
Report
- Report Number
- 3004209178-2013-03992
- Event Type
- Malfunction
- Date Received
- March 20, 2013
- Report Date
- March 6, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: RECHARGER: PRODUCT ID 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3708260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: EXTENSION. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT'S IMPLANT WAS "NOT ACTING RIGHT". ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 115565 | 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 |