BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 13091146 · Received December 27, 2021

    Report

    Report Number
    3006630150-2021-07301
    Event Type
    Injury
    Date Received
    December 27, 2021
    Date of Event
    November 30, 2021
    Report Date
    December 27, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS-MRI, UPN: M365SC2408740, MODEL: SC-2408-74, SERIAL: (B)(4), BATCH: 7072916. PRODUCT FAMILY: SCS-LINEAR LEADS-MRI, UPN: M365SC2408740, MODEL: SC-2408-74, SERIAL: (B)(4), BATCH: 7072041.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT EXPERIENCED FEELING PAIN WHERE THE IMPLANTABLE PULSE GENERATOR IPG WAS IMPLANTED. THE NURSE CHECKED THE SITE AND FOUND THAT THERE WAS A HOLE AND THE IPG WAS EXPOSED. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND UNDERWENT AN EXPLANT PROCEDURE OF THE SPINAL CORD STIMULATOR SYSTEM. POST OPERATIVELY, THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE PHYSICIAN ASSESSED THAT BECAUSE THE PATIENT'S SKIN IS HARD AND THIN, THE DEVICE MAY HAVE RUBBED AGAINST THE SKIN AND CAUSED A HOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1985904 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 522274 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R