BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 1950399 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22373
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    November 13, 2010
    Report Date
    January 10, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Removal / Correction Number
    123456
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS TO BE RETURNED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    AS NO ADDITIONAL INFORMATION CONCERNING THIS REPORT IS EXPECTED AT THIS TIME, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS DEVICE'S PROGRAMMED PARAMETER SETTINGS AND THERAPY HISTORY WERE USED TO ESTIMATE EXPECTED BATTERY USE TO DATE, THEN COMPARED TO ACTUAL USE. OUR INITIAL ANALYSIS SHOWED THIS DEVICE MET LONGEVITY EXPECTATIONS PER PROGRAMMED VALUES. 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. DEVICE TONES WERE APPROPRIATELY DELIVERED FOR THE DEVICE'S BATTERY STATUS. REVIEW OF DEVICE MEMORY SHOWED THE DEVICE DELIVERED FOUR SHOCKS WHILE IMPLANTED: THREE WERE INDUCED, AND THE ONE SPONTANEOUS EPISODE SHOWED THE DEVICE FUNCTIONED AS PROGRAMMED. OUR ANALYSIS AND TESTING DID NOT CONFIRM THE PATIENT ALLEGATIONS.

    Additional Manufacturer Narrative · 1

    A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT (TS) DISCUSSED WHY A DEVICE WILL DELIVER BEEPING TONES, INCLUDING AS A SIGNAL THAT ELECTIVE REPLACEMENT INDICATOR (ERI) STATUS HAS BEEN REACHED, AND THE PATTERN AND FREQUENCY THAT THE DEVICE USES WHEN EMITTING TONES. TS ADVISED THAT HAVING THE DEVICE INTERROGATED IS THE ONLY WAY TO DETERMINE IF AND WHY TONES ARE BEING EMITTED, AND THAT FOLLOW UP WITH A HEALTH CARE PROVIDER IS RECOMMENDED IF A PATIENT RECEIVES SHOCK THERAPY. THIS DEVICE IS INCLUDED IN THE (B)(6) 2007 SHORTENED REPLACEMENT WINDOW ADVISORY POPULATION; PREVIOUS DEVICE CHECKS SHOWED THE DEVICE WAS NOT EXHIBITING PREMATURE DEPLETION PER THE ADVISORY CRITERIA. DEVICE DATA PROVIDED FOR FOUR LONGEVITY ESTIMATE REQUESTS OVER A TWO-YEAR PERIOD SHOWED NO LEAD MEASUREMENT ANOMALIES. A BOSTON SCIENTIFIC FIELD REPRESENTATIVE WAS NOT AWARE OF THE ALLEGATIONS, AND HAD NO ADDITIONAL INFORMATION IMMEDIATELY AVAILABLE. THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A BOSTON SCIENTIFIC FIELD REPRESENTATIVE SUBSEQUENTLY REPORTED THAT THE TONES WERE DUE TO THE DEVICE BEING AT ERI STATUS. THE REPRESENTATIVE NOTED THAT THERE WERE NO DEVICE OR LEAD ANOMALIES NOTED, OTHER THAN THE PATIENT DID NOT HAVE A LEFT VENTRICULAR (LV) LEAD IMPLANTED FOR USE WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). DEVICE REPLACEMENT WAS PENDING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT'S SPOUSE ALLEGED THIS DEVICE'S BATTERY WAS PREMATURELY DEPLETING AND THAT THE DEVICE HAD PREVIOUSLY DELIVERED INAPPROPRIATE SHOCKS, POSSIBLY DUE TO A FRACTURED LEAD. THE SPOUSE REPORTED THE DEVICE WAS EMITTING BEEPING TONES, AND AT A DEVICE CHECK TWO WEEKS PREVIOUS, THE PATIENT HAD BEEN TOLD THE DEVICE WAS NEAR REPLACEMENT STATUS. THE SPOUSE CONTACTED THE PHYSICIAN'S OFFICE, AND WAS ADVISED TO CONTACT BOSTON SCIENTIFIC. THE SPOUSE ALSO REPORTED THAT ABOUT 2.5 YEARS PREVIOUS, THE PATIENT'S PHYSICIAN HAD LOWERED THE RATE FOR DELIVERY OF TACHYCARDIA THERAPY, AND THE RATE SUBSEQUENTLY HAD TO BE INCREASED DUE TO INAPPROPRIATE SHOCKS. THERE APPARENTLY WERE NO SUBSEQUENT EPISODES WITH SHOCK THERAPY DELIVERED.

    Description of Event or Problem · 1

    THE DEVICE SUBSEQUENTLY WAS EXPLANTED AND REPLACED WITH NO ADVERSE PATIENT EFFECTS. THE DEVICE'S REPORTING STATUS IS CHANGED TO SERIOUS INJURY FROM MALFUNCTION DUE TO EXPLANT WITH PREMATURE BATTERY DEPLETION PREVIOUSLY ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H177

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR 0158| H177| 4470