BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 18356843 · Received December 19, 2023

    Report

    Report Number
    3006630150-2023-07941
    Event Type
    Injury
    Date Received
    December 19, 2023
    Date of Event
    October 6, 2023
    Report Date
    December 19, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS. UPN: M365SC8336500. MODEL: SC-8336-50. SERIAL: (B)(6). BATCH: 7081936.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AND THE WOUND HAD BECOME DEHISCED. THE INFECTION WAS LOCATED IN THE RIGHT FLANK INCISION OVER THE IPG SITE. SYMPTOM INCLUDED GREEN DRAINAGE. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS NOT DEVICE RELATED AND THAT THE PATIENT HAD DIFFICULTY WITH DELAYED WOUND HEALING IN THE PAST. THE PATIENT WAS GIVEN ANTIBIOTICS AND THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) EXPLANT PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE NOT RETURNED AS THEY WERE SENT TO PATHOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1350263 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 576632 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Required Intervention