BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 2060151 · Received April 15, 2011

    Report

    Report Number
    2124215-2011-05841
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    August 24, 2007
    Report Date
    May 4, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST-MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. BASED ON RECORDED DATA FROM DEVICE OPERATIONS AND AN ENGINEERING CALCULATION BASED ON PROGRAMMED VALUES, THIS DEVICE MET LONGEVITY EXPECTATIONS. THE DEVICE WAS THEN PUT THROUGH AND PASSED A SERIES OF AUTOMATED DIAGNOSTIC TESTS THAT VERIFIED THE PERFORMANCE OF THE DEFIBRILLATION, PACING, SENSING, HIGH-VOLTAGE SHOCKING, AND RECORDING FUNCTIONS OF THE DEVICE. REVIEW OF THE DATA STORED IN DEVICE MEMORY SHOWED THE DEVICE REACHED EOL BATTERY STATUS ON THE DATE THAT HCP REPORTED THE DEVICE REACHED STORAGE MODE. THE DEVICE DID REACH STORAGE MODE TWO DAYS BEFORE EXPLANT, WHICH WAS 4.4 MONTHS AFTER EOL WAS REACHED.

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTED DEVICE HAD BEEN HOSPITALIZED WITH A HEART RATE IN THE RANGE OF 30 BEATS PER MINUTE (BPM). A HEALTH CARE PROVIDER (HCP) REPORTED THAT INTERROGATION SHOWED THE DEVICE HAD REACHED STORAGE MODE STATUS 4.5 MONTHS PRIOR TO THE PATIENT HOSPITALIZATION. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT (TS) DISCUSSED THAT THE DEVICE CANNOT PROVIDE BRADYCARDIA OR TACHYCARDIA THERAPY WHEN IT REACHES STORAGE MODE. THE DEVICE SUBSEQUENTLY WAS EXPLANTED AND REPLACED WITH NO SUBSEQUENT ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H170

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R 0158| (B)(4)| H170| 4543