BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELUTE PICOTIP

    MDR report key: 2910007 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15367
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 6, 2012
    Report Date
    November 7, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 DURING A ROUTINE FOLLOW-UP APPOINTMENT IT WAS NOTED THE SAFETY SWITCH HAD CHANGED THE PACING FROM BIPOLAR TO UNIPOLAR CONFIGURATION. IT WAS NOT POSSIBLE TO SEE WHEN THE HIGH IMPEDANCE MEASUREMENT HAD OCCURRED. THE HIGHEST IMPEDANCE VALUE INDICATED ON THE REPORT WAS 1450 OHMS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17471 SELUTE PICOTIP IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4340

    Patients

    Seq Age Sex Outcome Treatment
    1