BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELUTE PICOTIP

    MDR report key: 3951208 · Received July 22, 2014

    Report

    Report Number
    2124215-2014-14276
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    February 1, 2014
    Report Date
    July 21, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P950001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    --

    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 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT ATRIAL (RA) LEAD EXHIBITED LOW PACING IMPEDANCE MEASUREMENTS LESS THAN 200 OHMS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) SUSPECTED AN INSULATION BREAK DUE TO ATRIAL TACHY RESPONSE (ATR) EPISODE WHICH APPEARED TO BE NOISE FROM MYOPOTENTIAL OVERSENSING. THE PHYSICIAN ELECTED TO PROGRAM THE DEVICE TO VVI. NO FURTHER INTERVENTION WAS PERFORMED AT THIS TIME. THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    FURTHER INFORMATION RECEIVED INDICATED THAT LOW RA PACING LEAD IMPEDANCE MEASUREMENTS LESS THAN 200 OHMS CONTINUED TO BE OBSERVED. IT WAS REPORTED THAT THIS HAS BEEN AN ONGOING ISSUE WHICH HAD BECOME MORE FREQUENT IN THE LAST FEW MONTHS. THE PLAN WAS TO SCHEDULE AN IN-OFFICE FOLLOW UP TO EVALUATE THE ATRIAL LEAD. ADDITIONAL INFORMATION WAS UNABLE TO BE OBTAINED. THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428376 SELUTE PICOTIP IMPLANTABLE LEAD NVY CPI - DEL CARIBE 4064

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR 4064| 1851| E110| A155| 0145