BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S-ICD SYSTEM

    MDR report key: 3020828 · Received March 18, 2013

    Report

    Report Number
    3009448963-2013-00023
    Event Type
    Malfunction
    Date Received
    March 18, 2013
    Date of Event
    December 13, 2012
    Report Date
    February 28, 2013
    Manufacturer
    CAMERON HEALTH
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LAB, NO TELEMETRY COULD BE ESTABLISHED WITH THE SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) AFTER MULTIPLE ATTEMPTS. X-RAY IMAGING OF THE DEVICE SHOWED VOIDS AT THE CRYSTAL SOLDER JOINTS. DETAILED ANALYSIS CONFIRMED THAT A SOLDER JOINTS ON THE INTEGRATED CIRCUIT WERE CRACKED, RESULTING IN AN INTERMITTENT CONNECTION. CONFIRMED DEVICE RESPONSE TO MAGNET APPLICATION WAS NOTED. LOCALIZED HEATING AT SOLDER JOINTS RESULTED IN CORRECTION OF THE FAILURE MODE. THE DEVICE THEN EXHIBITED NORMAL OPERATION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFO THAT ON THE DAY OF IMPLANT, THE PROGRAMMER DID NOT RECOGNIZE THE PRESENCE OF A DEVICE. FOUR ATTEMPTS WERE MADE TO INTERROGATE THE DEVICE WITH REPOSITIONING OF THE WAND EACH TIME. A NEW PROGRAMMER WAS ALSO ATTEMPTED WITHOUT SUCCESS. AT THAT TIME THE DECISION TO NOT IMPLANT THIS DEVICE WAS MADE. A NEW DEVICE WAS SELECTED, WHICH WAS EASILY INTERROGATED BY BOTH PROGRAMMERS. AFTER THE PROCEDURE A MAGNET WAS PLACED OVER THE DEVICE AND AN AUDIBLE TONE COULD BE HEARD. ANOTHER ATTEMPT TO INTERROGATE THE DEVICE WAS MADE WITHOUT SUCCESS. THE NEXT STEP WAS PLACING A MAGNET AND WAND OVER THE DEVICE SIMULTANEOUSLY, AN AUDIBLE TONE WAS HEARD; HOWEVER, INTERROGATION WAS UNSUCCESSFUL. THE DEVICE WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111712 S-ICD SYSTEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CAMERON HEALTH 1010

    Patients

    Seq Age Sex Outcome Treatment
    1