FDA Adverse Event
Injury
Summary report: N
RESTORE
MDR report key: 5274945
·
Received December 8, 2015
Report
- Report Number
- 3004209178-2015-24001
- Event Type
- Injury
- Date Received
- December 8, 2015
- Date of Event
- November 12, 2015
- Report Date
- November 12, 2015
- 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
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 377775, LOT# V013204, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID 377775, LOT# V013204, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. (B)(4).
Description of Event or Problem · 1
THE MANUFACTURER REPRESENTATIVE REPORTED THAT THE IMPLANT WAS AT END OF SERVICE. THE PATIENT WENT TO THE PHYSICIAN AND THE END OF SERVICE WAS IDENTIFIED. THE FULL SYSTEM WAS REPLACED AND THE ISSUE WAS RESOLVED AT THE TIME OF THIS REPORT. NO PATIENT SYMPTOMS REPORTED. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 806259 | RESTORE | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37711 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00050 YR | Required Intervention |