FDA Adverse Event
Injury
Summary report: N
LINEAR? 3-6
MDR report key: 22294342
·
Received June 19, 2025
Report
- Report Number
- 3006630150-2025-04677
- Event Type
- Injury
- Date Received
- June 19, 2025
- Date of Event
- May 27, 2025
- Report Date
- June 19, 2025
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729789567
- 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: BRAND NAME: LINEAR? 3-6, UPN: M365SC2366700, MODEL: SC-2366-70, SERIAL: (B)(6), BATCH: 7073519, UPN: (B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPY FROM THE SPINAL CORD STIMULATION (SCS) SYSTEM. HIGH IMPEDANCES WERE DISPLAYED ON THE SCS LEADS. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE LEADS WERE REPLACED. THE PATIENT WAS RECOVERING AS EXPECTED POSTOPERATIVELY. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE RETAINED BY THE CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 853947 | LINEAR? 3-6 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-2366-70 | 7073484 | 08714729789567 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Female | Required Intervention |