FDA Adverse Event
Malfunction
Summary report: N
RESTORE ULTRA
MDR report key: 3790714
·
Received May 5, 2014
Report
- Report Number
- 3004209178-2014-08515
- Event Type
- Malfunction
- Date Received
- May 5, 2014
- Report Date
- April 14, 2014
- 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
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 39565-30, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE STIMULATION WAS TURNING ON AND OFF, WHICH BEGAN TWO DAYS AGO. IT WAS NOTED THAT THE PATIENT STATED THAT THEY COULD TURN STIMULATION ON AND OFF WITH THE PATIENT PROGRAMMER AND RECHARGER BUT DID NOT FEEL ANYTHING. IT WAS NOTED THAT THE PATIENT HAS HAD NO FALLS, ACCIDENTS OR TRAUMA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 267448 | 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 | 00040 YR |