BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 18540537 · Received January 18, 2024

    Report

    Report Number
    3006630150-2023-08635
    Event Type
    Injury
    Date Received
    January 18, 2024
    Date of Event
    December 2, 2023
    Report Date
    January 18, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS-MRI. UPN: M365SC2408560. MODEL: SC-2408-56. SERIAL: (B)(6). BATCH: 7081337.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO AN INFECTION. ALL DEVICE COMPONENTS WERE REMOVED AND WERE NOT RETURNED. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1140989 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1216 575828 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention