BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSVENOUS

    MDR report key: 3053191 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05668
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 14, 2013
    Report Date
    May 13, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    K893957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE RIGHT ATRIAL (RA) LEAD WAS TESTED IN BIPOLAR CONFIGURATION AND THE IMPEDANCE MEASUREMENT WAS STABLE WITHOUT ANY NOISE ON THE ELECTROGRAMS (EGMS). SUBSEQUENTLY THE LEAD WAS REPROGRAMMED TO BIPOLAR MODE. THE FIELD REPRESENTATIVE NOTED THAT NO X-RAY WAS TAKEN AND THE CAUSE OF THE LOW IMPEDANCE MEASUREMENTS REMAINS UNKNOWN. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    APPROXIMATELY FOURTEEN MONTHS LATER DURING AN INTERROGATION, THE RA LEAD WAS NOTED TO BE IN UNIPOLAR CONFIGURATION AGAIN DUE TO A LEAD SAFETY SWITCH. THE CLINICIAN STATED THAT IT WAS ALSO SEEN AT THE PREVIOUS INTERROGATION EIGHT MONTHS EARLIER. OVERSENSING OF NOISE ON THE ATRIAL CHANNEL LEADING TO INAPPROPRIATE ATRIAL TACHY RESPONSE (ATR) EVENTS WAS ALSO SEEN; THE NOISE WAS REPRODUCIBLE. IT WAS NOTED THAT THE RA IMPEDANCE MEASUREMENTS HAVE BEEN IN THE 300 OHM RANGE. THE CLINICIAN REPROGRAMMED THE RA LEAD BACK TO BIPOLAR CONFIGURATION. TS DISCUSSED FURTHER TROUBLESHOOTING. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE DEVICE INTERROGATION IT WAS NOTED THAT THE RIGHT ATRIAL (RA) LEAD SAFETY SWITCH HAD TRIPPED FOR A LOW OUT OF RANGE IMPEDANCE MEASUREMENT. OVERSENSING OF NOISE LEADING TO INAPPROPRIATE ATRIAL TACHY RESPONSE (ATR) MODE SWITCHES WAS ALSO OBSERVED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND SUGGESTED FURTHER TESTING OF THE LEAD ONCE IT WAS PROGRAMMED BACK TO BIPOLAR CONFIGURATION. THE FIELD REPRESENTATIVE IS ATTEMPTING TO OBTAIN ADDITIONAL INFORMATION FROM THE CLINIC. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156656 TRANSVENOUS IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4271

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR 4285| 1274| 1291| 4271