BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA PRIME 16

    MDR report key: 12724769 · Received October 29, 2021

    Report

    Report Number
    3006630150-2021-06100
    Event Type
    Injury
    Date Received
    October 29, 2021
    Date of Event
    October 6, 2021
    Report Date
    October 29, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985068
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(4), BATCH/LOT: 7082070/ 7090146. PRODUCT FAMILY: SCS-LEAD FIXATION, UPN: M365SC43180, MODEL: SC-4318, BATCH/LOT: 27648350.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION, AND A DISCHARGE WAS FOUND AT THE IPG SITE. THE PHYSICIAN DID NOT BELIEVE THAT THE INFECTION WAS DUE TO PROCEDURE OR DEVICE RELATED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS PRESCRIBED ANTIBIOTICS. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICES WERE NOT RETURNED. CULTURE WAS TAKEN AND THE RESULT SHOWED (B)(6) FOR STAPHYLOCOCCUS EPIDERMIDIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1619673 WAVEWRITER ALPHA PRIME 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1416 203170 08714729985068

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention