BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 2151694 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-06607
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    April 4, 2011
    Report Date
    May 31, 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

    ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE COULD NOT COMMUNICATE WITH RADIO FREQUENCY (RF) TELEMETRY. A LATITIUDE UPLOAD HAD NOT BEEN RECEIVED IN ALMOST A YEAR AND WHEN THE PATIENT WAS SEEN IN THE CLINIC RF COMMUNICATION WAS UNSUCCESSFUL. A TECHNICAL SERVICE CONSULTANT WAS CONTACTED AND RECOMMENDED PERFORMING A SAVE TO DISK AND MEMORY DUMP IF TROUBLE-SHOOTING WITH COMMUNICATOR WAS UNSUCCESSFUL. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED THAT RF COMMUNICATIONS HAVE NOT YET BEEN RESOLVED BETWEEN THIS DEVICE AND THE REMOTE MONITORING COMMUNICATOR. NO 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 H217

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR H217| 4470| 4517| MISMATCH| 0158