BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELUTE PICOTIP

    MDR report key: 3040676 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-00667
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    January 7, 2013
    Report Date
    February 8, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THE LEAD REAMINS IMPLANTED BUT ABANDONED ELECTRICALLY. THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS CHECKED AGAIN THE FOLLOWING MONTH. THE ATRIAL LEAD MEASUREMENTS WERE FOUND TO BE WITHIN NORMAL RANGE; SPECIFICALLY, THE PACING IMPEDANCE MEASUREMENT WAS 980 OHMS. HOWEVER, THE PATIENT WAS FEELING WELL AT THE CURRENT PROGRAMMING OF VVI MODE, SO NO PROGRAMMING CHANGES WERE MADE AT THIS TIME. THE PATIENT AND LEAD WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED PACING IMPEDANCE MEASUREMENTS OF LESS THAN 100 OHMS. NOISE AND OVERSENSING WERE OBSERVED IN BOTH BIPOLAR AND UNIPOLAR PACING CONFIGURATIONS. AN INSULATION ISSUE WAS SUSPECTED. THE DEVICE WAS REPROGRAMMED TO VVI MODE AND THE PATIENT WOULD CONTINUE TO BE MONITORED, WITH A FOLLOW-UP CHECK SCHEDULED FOR THE NEXT MONTH. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143869 SELUTE PICOTIP IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4063

    Patients

    Seq Age Sex Outcome Treatment
    1