BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWEET PICOTIP

    MDR report key: 6698575 · Received July 10, 2017

    Report

    Report Number
    2124215-2017-07552
    Event Type
    Malfunction
    Date Received
    July 10, 2017
    Date of Event
    April 21, 2017
    Report Date
    May 24, 2017
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 GENERATOR CHANGEOUT PROCEDURE THIS RIGHT ATRIAL (RA) LEAD SEPARATED FROM THE TERMINAL PIN. IT WAS STATED THAT AFTER TIGHTENING THE SETSCREW AND TUGGING ON THE LEAD IT CAME APART AT THE TERMINAL PIN. THE LEAD WAS STILL CONNECTED BY THE WIRE AND CONTINUED TO CAPTURE AND SENSE; HOWEVER, THE IMPEDANCES WERE VARIABLE BETWEEN 200-700 OHMS. IT WAS REPORTED THAT A LEAD SAFETY SWITCH (LSS) HAD BEEN TRIPPED. PROGRAMMING MODIFICATION WERE MADE. THE PHYSICIAN WAS USING LOCAL ANESTHESIA AND THE PATIENT HAD EATEN BEFOREHAND THEREFORE, THE PHYSICIAN DIDN'T WANT TO REVISE OR TAKE FURTHER ACTION AT THAT TIME. THE PATIENT PACED 80% OF THE TIME IN THE ATRIUM. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NO FURTHER ACTIONS HAVE BEEN PERFORMED AND THE PHYSICIAN PLANS TO MONITOR VIA THE REMOTE MONITORING SYSTEM.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATES THAT THIS LEAD WAS NOW EXHIBITING NOISE, INCREASED PACING THRESHOLDS AND POCKET STIMULATION. THE STIMULATION MAKES THE PATIENT UNCOMFORTABLE. THE LEAD CONTINUES TO TRIPPED LEAD SAFETY SWITCHES (LSS). THE PHYSICIAN PROGRAMMED THE PATIENT'S DEVICE TO SENSE AND PACE IN THE VENTRICLE ONLY AT 40 AND SENT THE PATIENT FOR X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478446 SWEET PICOTIP IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4053

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR 1280| 4053| 4054| L321| S603