BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA PRIME

    MDR report key: 16700711 · Received April 7, 2023

    Report

    Report Number
    3006630150-2023-01857
    Event Type
    Injury
    Date Received
    April 7, 2023
    Date of Event
    March 11, 2023
    Report Date
    April 7, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EXACT DATE: UNKNOWN, EVENT OCCURRED OVER THE WEEKEND FROM THE DATE THE MANUFACTURER WAS MADE AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS. UPN: M365SC8336500, MODEL: SC-7080806. SERIAL: (B)(4), BATCH: 7080806.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE IPG SITE. SYMPTOMS WERE FEVER AND CHILLS. THE PHYSICIAN PRESCRIBED AN ANTIBIOTIC, BUT SYMPTOMS PERSISTED. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS DUE TO SURGERY, AND IT WAS UNKNOWN IF IT WAS DEVICE RELATED. THE PATIENT UNDERWENT A FULL EXPLANT PROCEDURE, AND THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE KEPT BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520078 WAVEWRITER ALPHA PRIME STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1432 214163 08714729985075

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Required Intervention