BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 2170397 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-10399
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    May 31, 2011
    Report Date
    November 29, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. [PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS, WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Additional Manufacturer Narrative · 1

    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

    APPROXIMATELY ONE YEAR LATER THE DEVICE WAS EXPLANTED FOR REPORTED NORMAL BATTERY DEPLETION. APPROXIMATELY SIX MONTHS AFTER EXPLANT IT WAS RETURNED FOR STANDARD ANALYSIS TESTING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE DEVICE WAS INTERROGATED PRIOR TO THE PATIENT HAVING KNEE SURGERY. UPON INTERROGATION FOUR STORED EPISODES OF NOISE WITH OVERSENSING LEADING TO A DIVERTED VENTRICULAR FIBRILLATION (VF) EVENT AND SEVERAL EPISODES OF ASYSTOLE WERE SEEN. ALL THREE EPISODES OF ASYSTOLE WERE GREATER THAN TWO SECONDS AND NOISE WAS OBSERVED ON THE SHOCK AND RIGHT VENTRICULAR CHANNELS. THE PATIENT WAS NOTED TO BE PACEMAKER DEPENDENT AND EXPERIENCING ATRIAL FIBRILLATION. BOSTON SCIENTIFIC TECHNICAL SERVICES ADVISED THE SALES REPRESENTATIVE (SR) TO DISCUSS THE SITUATION WITH THE PHYSICIAN AND EVALUATE THE SYSTEM. THE SR STATED THAT THE PATIENT WAS NOT IN A CONDITION TO PERFORM ISOMETRICS, AND THE DEVICE WAS REPROGRAMMED TO LEAST SENSITIVE WITH AN INCREASE IN THE DURATION OF 2.5 SECONDS INTO THE VF ZONE. THE PHYSICIAN OKAYED THE PATIENT FOR THE KNEE SURGERY SINCE IT HAS BEEN PREVIOUSLY DECIDED SHE WOULD BE SENT TO THE INTENSIVE CARE UNIT FOLLOWING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS AVAILABLE AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H210

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR 4543| 1284| 4088| 4470| H210| 0185