FDA Adverse Event
Injury
Summary report: N
RESTORE ULTRA
MDR report key: 3015693
·
Received March 21, 2013
Report
- Report Number
- 3004209178-2013-04054
- Event Type
- Injury
- Date Received
- March 21, 2013
- Report Date
- March 4, 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
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID: 3998, LOT# V233248, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD; PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER; PRODUCT ID: 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION; PRODUCT ID: 3550-29, LOT# N277617, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: ACCESSORY; (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT HAD A LEAD THAT "SLIPPED" AND SURGERY WAS PERFORMED TO IMPLANT A PADDLE LEAD. THE PATIENT DID NOT GET FOLLOW UP AFTER THE PROCEDURE AS IT WAS REPORTEDLY NOT NEEDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 117108 | 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 |