FDA Adverse Event
Malfunction
Summary report: N
STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
MDR report key: 17537575
·
Received August 12, 2023
Report
- Report Number
- MW5144448
- Event Type
- Malfunction
- Date Received
- August 12, 2023
- Report Date
- September 20, 2010
- Manufacturer
- MEDTRONIC
- 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 THAT WOULD HAVE BEEN REPORTABLE UNDER 21 CFR 803, MEDICAL DEVICE REPORTING WITHIN OUR COMPLAINT SYSTEM. HOWEVER, THE EVENT REPORTED WAS RELATED TO THE IMPLANTED SPINAL CORD STIMULATOR MANUFACTURED BY MEDTRONIC. ON (B)(6) 2010, BSN BECAME AWARE THAT A PATIENT'S MEDTRONIC IPG WAS EXPLANTED AND REPLACED WITH A BSN PRECISION SYSTEM. THE REASON FOR THE MEDTRONIC IPG EXPLANT IS UNKNOWN. THE MEDTRONIC LEADS WERE EXPLANTED BECAUSE THE PHYSICIAN HAD ACCIDENTALLY PULLED OUT THE LEAD DURING THE PROCEDURE. 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 |
|---|---|---|---|---|---|---|---|
| 1073397 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |