FDA Adverse Event
Malfunction
Summary report: N
RESTORE ULTRA
MDR report key: 3040577
·
Received April 8, 2013
Report
- Report Number
- 3004209178-2013-04851
- Event Type
- Malfunction
- Date Received
- April 8, 2013
- Report Date
- February 27, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37743, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3 778-60, SERIAL# (B)(4). PRODUCT TYPE: LEAD: PRODUCT ID 37092, LOT# 287170001. PRODUCT TYPE: ACCESSORY: PRODUCT ID 355531, LOT# N297507. PRODUCT TYPE: SCREENING DEVICE: PRODUCT ID 3550-39, LOT# N282204. PRODUCT TYPE: ACCESSORY: PRODUCT ID 3550-29, LOT# N296231. PRODUCT TYPE: ACCESSORY: PRODUCT ID 37752, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PROGRAMMER DISPLAY SHOWED A "CALL YOUR DOCTOR" ICON AND AN OUT-OF-REGULATION (OOR) CONDITION HAD OCCURRED SEVERAL TIMES OVER THE PAST WEEK. THE ISSUE SEEMED TO HAVE RESOLVED AND WAS NO LONGER HAPPENING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 143127 | 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 | 00061 YR |