FDA Adverse Event
Injury
Summary report: N
LINEAR 3-6
MDR report key: 15229469
·
Received August 15, 2022
Report
- Report Number
- 3006630150-2022-04044
- Event Type
- Injury
- Date Received
- August 15, 2022
- Date of Event
- July 18, 2022
- Report Date
- August 15, 2022
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729789574
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: (B)(4). MODEL: SC-2366-70. SERIAL: (B)(4). LOT: 5142489.
Description of Event or Problem · 0
IT WAS REPORTED THAT HIGH IMPEDANCES WERE DISPLAYED ON THE PATIENTS SPINAL CORD STIMULATION LEADS. THE PATIENT UNDERWENT A LUMBOSACRAL LEAD REVISION PROCEDURE WHERE TWO LEADS WERE REPLACED. IT WAS NOTED THE LEADS WERE AGAIN PLACED SUBCUTANEOUSLY FOR LOCALIZED NERVE STIMULATION FOR PAIN CONTROL RATHER THAN IN THE EPIDURAL SPACE. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE LEADS WERE DISPOSED OF BY THE MEDICAL FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1945288 | LINEAR 3-6 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2366-50 | 5141446 | 08714729789574 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |