FDA Adverse Event
Injury
Summary report: N
RESTORE ULTRA
MDR report key: 4243840
·
Received November 11, 2014
Report
- Report Number
- 3004209178-2014-21337
- Event Type
- Injury
- Date Received
- November 11, 2014
- Report Date
- October 20, 2014
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD THE MANUFACTURER¿S IMPLANTABLE NEUROSTIMULATOR (INS) REMOVED AND HAD ANOTHER MANUFACTURER¿S INS IMPLANTED. THE DEVICE WAS NOT ABLE TO COVER THE PATIENT¿S PAIN BECAUSE OF ALL OF THE SCAR TISSUE. THE PATIENT WAS FUSED FROM L1 TO S1. THE MANUFACTURER ONLY HAD A FEW LEADS AND ANOTHER MANUFACTURER HAD MORE OPTIONS. THE PATIENT STATED THAT THEY WERE FULL OF RODS AND SCREWS. THE PATIENT THOUGHT THAT THE MANUFACTURER¿S LEADS REMOVED BUT WAS NOT SURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 725353 | 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 |