BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ICD SYSTEM

    MDR report key: 5241930 · Received November 22, 2015

    Report

    Report Number
    3009448963-2015-00635
    Event Type
    Injury
    Date Received
    November 22, 2015
    Date of Event
    October 29, 2015
    Report Date
    October 29, 2015
    Manufacturer
    CAMERON HEALTH
    Product Code
    NVY
    UDI-DI
    00802526530906
    PMA / PMN Number
    P11042
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 PRIOR TO THE IMPLANT OF THE SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) AND ELECTRODE THE PATIENT HAD LOST 80 TO 100 POUNDS AND WAS SELF CONSCIOUS OVER HAVING AN INCISION AT THE STERNUM. DUE TO THIS REASON THE PHYSICIAN OPTED TO USE THE TWO INCISION TECHNIQUE. HOWEVER, THE ELECTRODE HAD NOW BECOME DISLODGED AND HAD MIGRATED OVER THE LEFT LUNG. THE S-ICD ALSO MIGRATED. APPROXIMATELY ONE AND A HALF INCHES OF THE PATIENT'S SUBCUTANEOUS TISSUE ALSO MIGRATED AND WAS ON THE TOP BORDER OF THE S-ICD. A REVISION PROCEDURE WAS PERFORMED WHERE THE DEVICE AND ELECTRODE WERE REPOSITIONED. DEFIBRILLATION THRESHOLD (DFT) TESTING WAS NOT SUCCESSFUL THE FIRST TWO TIMES SO THE SYSTEM WAS REPOSITIONED AGAIN DURING THE SAME PROCEDURE. SUCCESSFUL DFT TESTING WAS ACHIEVED AFTER THE SECOND REPOSITIONING AND THE SYSTEM REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772037 S-ICD SYSTEM IMPLANTABLE LEAD NVY CAMERON HEALTH 3010 00802526530906

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| L| R