BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSVENOUS

    MDR report key: 2911898 · Received January 11, 2013

    Report

    Report Number
    2124215-2013-00121
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 14, 2012
    Manufacturer
    HISTORICAL CPI ST. PAUL
    Product Code
    NVN
    PMA / PMN Number
    K893957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE DEVICE WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI), IT WILL BE REPLACED IN THE NEAR FUTURE FOR NORMAL BATTERY DEPLETION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT WILL BE UPDATED IF MORE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE LEAD REMAINS IN SERVICE AT THIS TIME. 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

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEVICE CHANGEOUT DID OCCUR FOR NORMAL BATTERY DEPLETION AS PLANNED WITH NO FURTHER ISSUES NOTED. THE LEAD WAS CHECKED AT THE CHANGEOUT WITH NO PROBLEMS NOTED, THEREFORE NO REMEDIAL ACTION WAS REQUIRED AND THE LEAD REMAINS IMPLANTED WITH THE REPLACEMENT PULSE GENERATOR. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT UPON INTERROGATION OF THE DEVICE ASSOCIATED WITH THIS RIGHT VENTRICULAR LEAD AT A RECENT FOLLOW UP, PACING WAS NOT DELIVERED FOR 4 TO 5 SECONDS FOR THIS PACEMAKER DEPENDENT PATIENT. ONCE THE INTERROGATION WAS COMPLETE, THE DEVICE PACED AS INTENDED. IT WAS NOTED THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THE ASYSTOLE OR ISSUE. IT WAS SUSPECTED OVERSENSING OF NOISE ON THE RIGHT VENTRICULAR LEAD MAY HAVE BEEN THE CAUSE OF THE ISSUE, HOWEVER, THE DEFINITIVE ROOT CAUSE WAS UNDETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18106 TRANSVENOUS IMPLANTABLE LEAD NVN HISTORICAL CPI ST. PAUL 4261

    Patients

    Seq Age Sex Outcome Treatment
    1 0936| 4261| 4269