BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 20334831 · Received September 30, 2024

    Report

    Report Number
    3006630150-2024-06525
    Event Type
    Injury
    Date Received
    September 30, 2024
    Date of Event
    September 5, 2024
    Report Date
    September 30, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS; UPN: M365SC8216500; MODEL: SC-8216-50; SERIAL: (B)(6); BATCH: 7073150.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE IMPLANTABLE PULSE GENERATOR (IPG) POCKET SITE. THE PHYSICIAN DOES NOT THINK THAT THE INFECTION WAS DEVICE RELATED AND THE CAUSE WAS NOT KNOWN. THE PATIENT UNDERWENT A SPINAL CORD STIMULATION (SCS) EXPLANT PROCEDURE. NO DEVICE MALFUNCTION SUSPECTED. THE PATIENT WAS PRESCRIBED ANTIBIOTICS. THE EXPLANTED DEVICE COMPONENTS WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1061295 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1216 763192 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention