BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 20287308 · Received September 23, 2024

    Report

    Report Number
    3006630150-2024-06374
    Event Type
    Injury
    Date Received
    September 23, 2024
    Date of Event
    March 13, 2024
    Report Date
    September 23, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: BRAND NAME: COVEREDGE MRI, UPN: M365SC8436500, MODEL: SC-8436-50, SERIAL: (B)(6), BATCH: 7080444. BRAND NAME: CLIK X, UPN: M365SC43180, MODEL: SC-4318, SERIAL: N/A, BATCH: 30814392.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE IPG POCKET SITE. THE PHYSICIAN ASSESSED THE PAIN WAS DUE TO THE PRESENCE OF THE IPG AS THE PATIENT WAS SKINNY. THERE WAS NO FAULT WITH THE IPG. THE PATIENT UNDERWENT A SYSTEM EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE DEVICES WILL NOT BE RETURNED AS THEY WERE RETAINED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1090999 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 591318 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 10 MO Female Required Intervention