BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 19274190 · Received May 8, 2024

    Report

    Report Number
    3006630150-2024-02986
    Event Type
    Injury
    Date Received
    May 8, 2024
    Date of Event
    April 16, 2024
    Report Date
    August 15, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7096551/7096818.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7101979/7103188.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS WOUND WAS OPENED AND HAD DEVELOPED A SMALL HOLE OVER IPG SITE WHERE A CLEAR FLUID WAS NOTED. THE PATIENTS WOUND WAS CLEANED AND COVERED WITH STERILE STRIPS AND MEDICAL DRESSING. ANTIBIOTICS WERE PRESCRIBED. ADDITIONAL INFORMATION RECEIVED THAT THE PATIENT HAD A POCKET INFECTION AND FLUID COLLECTION AT THE LEAD SITE. THE PATIENT UNDERWENT A POCKET REVISION. IT WAS NOTED THAT DURING A POSTOPERATIVE VISIT, POOR WOUND HEALING WITH DEHISCENCE AND WOUND BREAKDOWN OF RIGHT FLANK WERE NOTED. THE PHYSICIAN ELECTED TO EXPLANT THE IPG ONLY AS THE PATIENT WAS UNABLE TO WITHHOLD ON BLOOD THINNERS. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICE WILL NOT BE RETURNED PER FACILITY POLICY. IT WAS ALSO NOTED THAT THE PATIENT WAS HAVING TROUBLE CHARGING THE IPG.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS WOUND WAS OPENED AND HAD DEVELOPED A SMALL HOLE OVER IPG SITE WHERE A CLEAR FLUID WAS NOTED. THE PATIENTS WOUND WAS CLEANED AND COVERED WITH STERILE STRIPS AND MEDICAL DRESSING. ANTIBIOTICS WERE PRESCRIBED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD A POCKET INFECTION AND FLUID COLLECTION AT THE LEAD SITE. IT WAS ALSO NOTED THAT THE PATIENT WAS HAVING TROUBLE CHARGING THE IPG. THE PATIENT UNDERWENT A POCKET REVISION. IT WAS NOTED THAT DURING THE POSTOPERATIVE VISIT, POOR WOUND HEALING WITH DEHISCENCE AND WOUND BREAKDOWN OF RIGHT FLANK WERE NOTED. THE PHYSICIAN ELECTED TO EXPLANT THE IPG ONLY AS THE PATIENT WAS UNABLE TO WITHHOLD ON BLOOD THINNERS. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICE WILL NOT BE RETURNED PER FACILITY POLICY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE LEADS THAT REMAINED WERE EXPOSED THROUGH THE AREA OF DEHISCENCE AT THE PRIOR IPG SITE AND A YELLOW-GREENISH SEROUS DRAINAGE WAS NOTED. THE INCISION HAD OPENED UP AND PATIENT DEVELOPED AN INFECTION. THE PATIENT UNDERWENT AN EXPLANT OF ALL THE REMAINING LEADS. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICES WERE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS WOUND WAS OPENED AND HAD DEVELOPED A SMALL HOLE OVER IPG SITE WHERE A CLEAR FLUID WAS NOTED. THE PATIENTS WOUND WAS CLEANED AND COVERED WITH STERI STRIPS AND MEDICAL DRESSING. ANTIBIOTICS WERE PRESCRIBED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140718 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 523594 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention