BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 20810973 · Received November 29, 2024

    Report

    Report Number
    3006630150-2024-08251
    Event Type
    Injury
    Date Received
    November 29, 2024
    Date of Event
    October 11, 2024
    Report Date
    November 29, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED, BASED ON THE DATE. THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: M365SC8336500, MODEL: SC-8336-50, SERIAL#: (B)(6), BATCH: 7082412. PRODUCT FAMILY: SCS-LEAD FIXATION, UPN: M365SC43160, MODEL: SC-4316, BATCH: 31528570.

    Description of Event or Problem · 0

    IT WAS REPORTED, THAT THE PATIENT UNDERWENT SPINAL CORD STIMULATOR (SCS) EXPLANT PROCEDURE, DUE TO AN UNKNOWN REASON. ALL EXPLANTED DEVICE COMPONENTS WILL NOT BE RETURNED, PER HOSPITAL POLICY. NO FURTHER INFORMATION COULD BE OBTAINED, DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2438872 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 566127 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention