FDA Adverse Event
Injury
Summary report: N
RESTORE ULTRA
MDR report key: 2925767
·
Received January 22, 2013
Report
- Report Number
- 3004209178-2013-00853
- Event Type
- Injury
- Date Received
- January 22, 2013
- Report Date
- January 3, 2013
- 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
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD. PRODUCT TYPE: LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THEY HAD "REVISED THE PATIENT'S SURGERY" BECAUSE THE IMPLANTABLE NEUROSTIMULATOR WAS NOT PUT IN THE RIGHT AREA. NO FURTHER INFORMATION WAS REPORTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT. REFER TO MANUFACTURER REPORT #3004209178-2013-00852 FOR INFORMATION REGARDING THE DEVICE NOT BEING IMPLANTED PROPERLY AND LEADS IN THE WRONG LOCATION.
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS FRUSTRATED AND WAS STILL HAVING CONCERNS, BUT WORKING WITH AN HCP OR MANUFACTURER REPRESENTATIVE TO RESOLVE THEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 29380 | 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 |