FDA Adverse Event
Injury
Summary report: N
RESTORE
MDR report key: 4090624
·
Received September 15, 2014
Report
- Report Number
- 3007566237-2014-02594
- Event Type
- Injury
- Date Received
- September 15, 2014
- Report Date
- June 4, 2014
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ADDITIONAL INFORMATION REPORTED THE EVENT WAS "OVER" AND THAT "THE PATIENT HAD HEALED."
Description of Event or Problem · 1
IT WAS REPORTED THAT AFTER THE PATIENT WAS IMPLANTED WITH A SPINAL CORD STIMULATION (SCS) SYSTEM THAT ¿EVERYTHING WENT WELL BUT HIS BODY REJECTED THE WIRE OF THE LEAD.¿ IT WAS STATED THE LEAD HAD BEEN REPLACED AND THAT ¿THIS HAPPENED THREE TIMES.¿ NO FURTHER DETAILS, INTERVENTIONS, OR AN OUTCOME WERE REPORTED REGARDING THIS EVENT. ADDITIONAL INFORMATION COULD NOT BE OBTAINED AT THE TIME OF THE REPORT. SHOULD ADDITIONAL INFORMATION BE RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 569683 | RESTORE | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC NEUROMODULATION | NEU_INS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |