BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 15951483 · Received December 9, 2022

    Report

    Report Number
    3006630150-2022-06591
    Event Type
    Injury
    Date Received
    December 9, 2022
    Date of Event
    March 10, 2022
    Report Date
    November 28, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(4), BATCH: 7083821 / 7083838; PRODUCT FAMILY: SCS-LEAD FIXATION, UPN: M365SC43160, MODEL: SC-4316, SERIAL: NA, BATCH: 27445877.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A NEW PAIN IN THE LEFT BUTTOCK FOLLOWING AN IMPLANT PROCEDURE. THE PHYSICIAN SUSPECTED THAT THE PAIN WAS DEVICE RELATED. IT WAS NOTED THAT THERE WAS A POSSIBILITY THAT ONE OF THE LEADS MIGHT BE PUSHING ON A NERVE. REPROGRAMMING WAS ATTEMPTED AND THE PATIENT GOT SOME PAIN RELIEF FOR A SHORT PERIOD OF TIME. THE PATIENT HAD INADEQUATE PAIN RELIEF DESPITE MULTIPLE REPROGRAMMING ATTEMPTS. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE. THE EXPLANTED DEVICES WERE NOT RETURNED AS THEY WERE KEPT BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2543963 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1216 532240 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Required Intervention