BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ICD PULSE GENERATOR

    MDR report key: 2915094 · Received January 10, 2013

    Report

    Report Number
    3009448963-2013-00001
    Event Type
    Injury
    Date Received
    January 10, 2013
    Date of Event
    November 15, 2012
    Report Date
    November 21, 2012
    Manufacturer
    CAMERON HEALTH INC
    Product Code
    LWS
    PMA / PMN Number
    P11042
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY CAMERON HEALTH'S QUALITY LABORATORY. INITIAL ANALYSIS OF THE DEVICE DATA CONFIRMED THE ERROR CONDITION OBSERVED IN THE FIELD. THERAPY AVAILABILITY WAS CONFIRMED. FURTHER INVESTIGATION IS SCHEDULED TO DETERMINE THE ROOT CAUSE. THIS INVESTIGATION WILL BE UPDATED UPON COMPLETION OF ANALYSIS. DHR REVIEW WAS CONDUCTED AND VERIFIED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATIONS PRIOR TO DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    CAMERON HEALTH RECEIVED INFORMATION THAT UPON CONNECTING TO THE PULSE GENERATOR AFTER IMPLANT, A RED SCREEN ERROR WAS OBSERVED ON THE PROGRAMMER. IT WAS REPORTED THAT THE PROGRAMMER DISPLAYED A PD (PATIENT DATA) ERROR. THREE ATTEMPTS WERE MADE TO CONNECT WITH THE PULSE GENERATOR, INCLUDING A PROGRAMMER RESET IN-BETWEEN. ALL CONNECTION ATTEMPTS LED TO A RED SCREEN WITH THE PD ERROR. AS A RESULT, THE PULSE GENERATOR WAS EXPLANTED AND REPLACED WITH NEW PULSE GENERATOR. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE EXPLANTED DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13881 S-ICD PULSE GENERATOR S-ICD PULSE GENERATOR LWS CAMERON HEALTH INC 1010EU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R