FDA Adverse Event
Injury
Summary report: N
RESTORE ULTRA
MDR report key: 2881842
·
Received December 20, 2012
Report
- Report Number
- 3004209178-2012-12082
- Event Type
- Injury
- Date Received
- December 20, 2012
- Report Date
- November 29, 2012
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 3778-60, SERIAL # (B)(4), PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL # (B)(4), PRODUCT TYPE LEAD; PRODUCT ID 3777-45, SERIAL # (B)(4), PRODUCT TYPE LEAD; PRODUCT ID 3777-45, SERIAL # (B)(4), PRODUCT TYPE LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED IN THE PAST THE PATIENT HAD A WIRE COME OUT OF THE SKIN AND THEY HAD TO HAVE IT REVISED. IT WAS NOTED BEFORE THE REVISION THE DEVICE WAS OPERATING "NORMALLY." IT WAS ALSO NOTED THERE WAS "BLEEDING AND THEN THEY HAD THE REVISION." SINCE THE REVISION, "THE DEVICE HASN'T BEEN THE SAME." NO FURTHER INFORMATION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 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 | Required Intervention |