FDA Adverse Event
Injury
Summary report: N
RESTORE ULTRA
MDR report key: 3133616
·
Received May 29, 2013
Report
- Report Number
- 3004209178-2013-08226
- Event Type
- Injury
- Date Received
- May 29, 2013
- Date of Event
- April 1, 2013
- Report Date
- May 8, 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
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
FINAL DEVICE ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) REVEALED THE FOLLOWING: NO SIGNIFICANT ANOMALY FOUND. THE INS HAD A REDUCED CAPACITY DUE TO THE OVERDISCHARGE.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT¿S SPINAL CORD STIMULATOR WAS REPLACED DUE TO ¿OLD STIMULATOR NOT WORKING.¿ IT WAS NOTED THAT THERE WAS NO PATIENT INJURY AND THAT THE PATIENT RECOVERED WITHOUT SEQUELA. IT WAS FURTHER NOTED THAT THE PATIENT WAS ¿NEW TO THE PRACTICE AND NO HISTORY WAS KNOWN OF THE OLD DEVICE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 235181 | 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 | 00057 YR | Required Intervention |