BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 20726871 · Received November 19, 2024

    Report

    Report Number
    3006630150-2024-07968
    Event Type
    Injury
    Date Received
    November 19, 2024
    Date of Event
    October 26, 2024
    Report Date
    December 15, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LEAD FIXATION-MRI, UPN: M365SC43190, MODEL: SC-4319, BATCH: 33825829, PRODUCT FAMILY: SCS-LINEAR LEADS-MRI, UPN: M365SC2408560, MODEL: SC-2408-56, SERIAL: (B)(6), BATCH: 7080169/7081178.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AND THE PHYSICIAN WAS UNABLE TO DETERMINE THE CAUSE. IT WAS NOTED THAT A BUBBLE FORMED AT THE ANCHORING INCISION AND WHEN THE PATIENT'S SON POPPED THE AREA, THE ANCHOR CAME OUT OF THE INCISION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. THERE WERE NO REPORTED COMPLICATIONS POSTOPERATIVELY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE EXPLANTED DEVICE COMPONENTS WERE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AND THE PHYSICIAN WAS UNABLE TO DETERMINE THE CAUSE. IT WAS NOTED THAT A BUBBLE FORMED AT THE ANCHORING INCISION AND WHEN THE PATIENT'S SON POPPED THE AREA, THE ANCHOR CAME OUT OF THE INCISION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. THERE WERE NO REPORTED COMPLICATIONS POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2422653 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 755919

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Required Intervention