FDA Adverse Event
Malfunction
Summary report: N
STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
MDR report key: 17531532
·
Received August 12, 2023
Report
- Report Number
- MW5138446
- Event Type
- Malfunction
- Date Received
- August 12, 2023
- Report Date
- January 9, 2012
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
BOSTON SCIENTIFIC NEUROMODULATION (BSN) RECEIVED INFORMATION ABOUT AN EVENT ON (B)(6) 2011 THAT WOULD HAVE BEEN REPORTABLE UNDER 21 CFR 803, MEDICAL DEVICE REPORTING WITHIN OUR COMPLAINT SYSTEM. HOWEVER, THE ISSUE REPORTED WAS RELATED TO A MEDTRONIC SPINAL CORD STIMULATOR. THE INFORMATION RECEIVED STATED THAT THE PATIENT'S MEDTRONIC SPINAL CORD STIMULATOR WAS EXPLANTED DUE TO HIGH IMPEDANCES. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1216579 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC NEUROMODULATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |