BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ICD SYSTEM

    MDR report key: 4407100 · Received January 8, 2015

    Report

    Report Number
    3009448963-2015-00004
    Event Type
    Injury
    Date Received
    January 8, 2015
    Date of Event
    December 10, 2014
    Report Date
    December 19, 2014
    Manufacturer
    CAMERON HEALTH
    Product Code
    LWS
    PMA / PMN Number
    P11042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: THIS REPORT IS BEING FILED TO ADD A DEVICE OBSERVATION CODE THAT WAS MISSING FROM THE INITIAL REPORT. (B)(4).

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT APPROXIMATELY A WEEK AND A HALF PRIOR TO THE IMPLANT OF THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM, THE PATIENT FELL OF HIS LEFT SHOULDER AND SIDE. THE DAY AFTER THE FALL, THE PATIENT WENT TO THE EMERGENCY ROOM, AN X-RAY WAS TAKEN, NO FRACTURE WAS IDENTIFIED, AND THE PATIENT WAS RELEASED TO HOME. PREOPERATIVELY, ON THE DAY ODF THE S-ICD IMPLANT, THE PATIENT REPORTED INTENSE LEFT SHOULDER PAIN TO THE HOSPITAL STAFF, BUT THE IMPLANTING PHYSICIAN WAS NOT MADE AWARE. THE PATIENT WAS PREPPED AND DRAPED IN A NORMAL FASHION WITH THE LEFT ARM EXTENDED APPROXIMATELY 60 DEGREES AND SECURED. AS PART OF THE IMPLANT PROCEDURE AND OPTIMIZATION, DEFIBRILLATION THRESHOLD (DFT) TESTING WAS PERFORMED AND THERE WAS NON-CONVERSION ON TWO OCCASIONS WITH EXTERNAL DEFIBRILLATION DONE EACH TIME. THE GENERATOR CAN WAS THEN REPOSITIONED AND REPEAT DFT TESTING WAS DONE WHICH WAS SUCCESSFUL. IT WAS NOTED THE PATIENT'S LEFT SIDE ROSE AND CAME OFF THE TABLE WITH THE TESTING. AT THE POST-OPERATIVE EVALUATION THE NEXT DAY, THE PATIENT COMPLAINED OF LEFT SHOULDER PAIN AND THERE WAS SWELLING PRESENT. A LEFT HUMERUS FRACTURE WAS DIAGNOSED AND SURGICAL INTERVENTION TO THE SHOULDER WAS PERFORMED TWO DAYS POST S-ICD IMPLANT. THE IMPLANTING PHYSICIAN BELIEVES THAT THE FALL INITIATED THE SHOULDER ISSUE AND THAT THE DFT TESTING AGGRAVATED IT. THE PATIENT WAS DISCHARGED AND IS NOW DOING FINE WITH NO FURTHER ADVERSE EFFECTS REPORTED. THE S-ICD SYSTEM REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17131 S-ICD SYSTEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CAMERON HEALTH 1010

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| R