BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 17741273 · Received September 13, 2023

    Report

    Report Number
    3006630150-2023-05537
    Event Type
    Injury
    Date Received
    September 13, 2023
    Date of Event
    August 25, 2023
    Report Date
    September 13, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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-MRI, UPN: M365SC2408560, MODEL: SC-2408-56, SERIAL: (B)(6), BATCH: 7081048/7080980.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE IPG SITE. IT WAS MENTIONED THAT THE PATIENT HAD A FALL WHICH CAUSED THE INCISION TO SLIGHTLY OPEN AND THE PATIENT DID NOT SEEK TREATMENT. IT WAS ALSO NOTED THAT THE PATIENT EXPERIENCED INCONTINENCE AND CONFUSION. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS NOT DEVICE NOR PROCEDURE RELATED. THE PATIENT WAS PUT ON ANTIBIOTICS AND UNDERWENT AN EXPLANT PROCEDURE WHEREIN ALL DEVICE COMPONENTS WERE REMOVED. THE PATIENT WAS HOSPITALIZED AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE NOT RETURNED AS THEY WERE KEPT BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2060194 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 578113 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Hospitalization| R