BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELUTE PICOTIP

    MDR report key: 2780118 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-11923
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 4, 2012
    Report Date
    April 7, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED NOTED THAT A FOLLOW UP TOOK PLACE. NOISE WAS SEEN ON THE ATRIAL CHANNEL, AS WELL AS CONTINUED OUT OF RANGE LOW PACING IMPEDANCES AND INTERMITTENT LOSS OF CAPTURE DUE TO AN INCREASE IN PACING THRESHOLDS. A POTENTIAL INSULATION ISSUE ON THIS RIGHT ATRIAL LEAD WAS SUSPECTED. THE PATIENT DOES NOT REQUIRE MUCH PACING FROM THE ATRIAL LEAD, THUS THE LEAD WAS NOT REPLACED AND NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PHYSICIAN ELECTED TO LEAD THE RIGHT ATRIAL LEAD IMPLANTED WITH NO PROGRAMMING CHANGES AND WILL EXPLANT THE LEAD UPON NORMAL DEVICE CHANGEOUT AT A LATER DATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED WHICH NOTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO A NORMAL DEVICE CHANGEOUT PROCEDURE. IT WAS NOTED THAT THIS RIGHT ATRIAL LEAD SHOWED NOISE AND THE LEAD WAS CONFIRMED TO BE FRACTURED. LOW OUT OF RANGE PACING IMPEDANCES WERE ALSO OBSERVED. THIS RIGHT ATRIAL LEAD WAS SURGICALLY ABANDONED AND WILL NOT BE RETURNED. A NEW LEAD WAS IMPLANTED SUCCESSFULLY. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS INVESTIGATION WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    -

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW UP LOW OUT OF RANGE PACING IMPEDANCES WERE NOTED ON THIS RIGHT ATRIAL LEAD. IN ADDITION, HIGH THRESHOLDS AND OVERSENSING WERE NOTED. A REPLACEMENT PROCEDURE WAS DISCUSSED AT THE TIME OF THE DEVICE CHANGEOUT. A FOLLOW UP WAS SCHEDULED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| R