BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 16011848 · Received December 20, 2022

    Report

    Report Number
    3006630150-2022-07101
    Event Type
    Injury
    Date Received
    December 20, 2022
    Date of Event
    August 19, 2022
    Report Date
    December 20, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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: M365SCC221820; MODEL: SC-2218-50; SERIAL: (B)(4); BATCH: 7110726/7111707.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS HAVING INFECTION AT THE IPG SITE AND MIDLINE SITE. SYMPTOMS OF DRAINAGE, TENDERNESS UPON PALPATION WERE NOTED. IT WAS ALSO REPORTED THAT THERE WAS A SMALL OPEN WOUND AT THE MIDLINE INCISION WHEREIN THE LEAD CAN BE SEEN. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS NOT DEVICE RELATED AND PROCEDURE RELATED. THE PATIENT HAD WOUND CARE AND WAS PLACED ON ANTIBIOTICS. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED IPG AND LEAD WERE DISCARDED PER HOSPITAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2571304 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1216 545580 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention