BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ICD SYSTEM

    MDR report key: 4203022 · Received October 23, 2014

    Report

    Report Number
    3009448963-2014-00223
    Event Type
    Injury
    Date Received
    October 23, 2014
    Date of Event
    August 26, 2014
    Report Date
    September 26, 2014
    Manufacturer
    CAMERON HEALTH INC.
    Product Code
    LWS
    PMA / PMN Number
    P11042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    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. THIS MDR WAS PREVIOUSLY SUBMITTED AS REPORT # 9912058-2014-00081 ON 09-25-2014 (ON-TIME). THIS IS A RE-SUBMISSION OF THE REPORT UNDER A VALID MANUFACTURER REGISTRATION NUMBER FOR FDA PROCESSING INTO MAUDE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) HAD A SMALL SCAB OVER THE DEVICE AREA AND WAS INSTRUCTED NOT TO SWIM. HOWEVER, THE PATIENT SWAM AND THE TISSUE BECAME INFECTED. SUBSEQUENTLY, SURGICAL REVISION OF THE INCISION SITE WAS PERFORMED AND THE SYSTEM REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. FURTHER INFORMATION WAS RECEIVED THAT THE PREVIOUS ATTEMPT TO REVISE THE INCISION WAS NOT SUCCESSFUL. THE INCISION DID NOT HEAL AND INFECTION AND EROSION WERE NOTED AROUND THE DEVICE. SUBSEQUENTLY, THE S-ICD SYSTEM WAS EXPLANTED. FURTHER INFORMATION WAS PROVIDED BY THE PATIENT'S FAMILY MEMBER THAT THE LATERAL MUSCLES OF THE CHEST WERE NOT DEVELOPED ENOUGH TO SUPPORT THE DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675393 S-ICD SYSTEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CAMERON HEALTH INC. 1010

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Hospitalization| L| R 3010