BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 20850279 · Received December 4, 2024

    Report

    Report Number
    3006630150-2024-08391
    Event Type
    Injury
    Date Received
    December 4, 2024
    Date of Event
    November 6, 2024
    Report Date
    December 4, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EXPLANT DATE USED AS THE APPROXIMATED DATE OF EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: M365SC2317500. MODEL: SC-2317-50. SERIAL: (B)(6). BATCH: 7082255. PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: M365SC2318500, MODEL: SC-2318-50, SERIAL: (B)(6), BATCH: 5001176.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS INCISIONS WERE NOT HEALING WELL FOLLOWING THE IMPLANT PROCEDURE. THE PHYSICIAN BELIEVED THAT THE PATIENT HAD A REACTION TO THE SUTURE THAT WAS USED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. ALL DEVICE COMPONENTS WERE REMOVED AND NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1942621 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 760679 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Required Intervention