BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 17835583 · Received September 28, 2023

    Report

    Report Number
    3006630150-2023-05889
    Event Type
    Injury
    Date Received
    September 28, 2023
    Date of Event
    September 8, 2023
    Report Date
    September 28, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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; UPN: M365SC2317700; MODEL: SC-2317-70; SERIAL: (B)(6); BATCH: 7082733/7082580.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE IPG SITE. IT WAS NOTED THAT THE SITE WAS RED, SWOLLEN, IRRITATED AND HAD PUS FORMATION. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS DUE TO THE EAR INFECTION THAT THE PATIENT HAD AND BECAME SYSTEMIC. THE PATIENT WAS HOSPITALIZED AND WAS GIVEN INTRAVENOUS ANTIBIOTICS. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND THE PATIENT WAS REPORTEDLY DOING WELL POSTOPERATIVE. NO DEVICE MALFUNCTION WAS SUSPECTED. THE EXPLANTED DEVICE WAS NOT RETURNED AS IT WAS KEPT BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2063105 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 577204 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Required Intervention| H