FDA Adverse Event
Malfunction
Summary report: N
SURESCAN
MDR report key: 5299686
·
Received December 15, 2015
Report
- Report Number
- 3004209178-2015-25108
- Event Type
- Malfunction
- Date Received
- December 15, 2015
- Date of Event
- November 20, 2015
- Report Date
- November 20, 2015
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE CONSUMER REPORTED AN ELECTIVE REPLACEMENT INDICATOR (ERI) ON A NON-RECHARGEABLE IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT HAD A CT SCAN TODAY AND TURNED STIMULATION OFF. NOW THEY SEE AN ERI AND CANNOT TURN STIMULATION BACK ON. IT WAS REPORTED THAT THEY TRIED TO BYPASS THE ERI MESSAGE BUT THE CONSUMER ONLY GOT A POOR COMMUNICATION OR ERI SCREEN. NO SYMPTOMS WERE REPORTED. RELEVANT MEDICAL HISTORY INCLUDES NON-MALIGNANT PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 826257 | SURESCAN | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 97702 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00070 YR |