BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWEET PICOTIP

    MDR report key: 3210271 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08234
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    January 11, 2013
    Report Date
    April 15, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DISC ANALYSIS WAS PERFORMED IN WHICH THE FOLLOWING OBSERVATIONS WERE NOTED. THE DEVICE HAS NO RESETS AND NO MEMORY ERRORS. THE DEVICE WAS IMPLANTED 3.6 YEARS AGO. THE DEVICE IS OPERATING IN THE 2ND TO THE HIGHEST CURRENT BIN AND SHOULD BE INDICATING 30% REMAINING ON THE BATTERY INDICATOR. ACCORDING TO MERLIN CALL LOGS THE DEVICE HAD PREVIOUSLY BEEN PROGRAMMED TO LOWER SETTINGS AUTOMATIC CAPTURE (AC) WAS CONFIRMED TO BE PROGRAMMED ON. THE AC DATA SHOWS THE PACING THRESHOLDS TO BE AS HIGH AS 2.7 VOLTS (V) AND WITH THE 0.5V MARGIN ADDED IT GIVES 3.2V. WITH THE MOST RECENT PROGRAMMED SETTINGS OF SSIR XL+MV, LOWER RATE LIMIT (LRL) 70, 5.0V AT 0.5 MILLISECONDS (MS) THE ESTIMATED LONGEVITY IS 3.8 YEARS. ACCORDING TO THE DEVICE CURRENT REMAINING AND CURRENT USED CALCULATIONS THE DEVICE SHOULD HAVE ABOUT 1 YEAR REMAINING LONGEVITY. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT IT IS CLINICAL DISCRETION IF THEY WANT TO CHANGE OUT LEAD AT NEXT DEVICE CHANGE-OUT, AS DO NOT KNOW IF AC/CAPTURE ISSUES WERE BECAUSE OF A LEAD ISSUE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT WAS RECEIVED THAT AT A LATER DATE THIS PATIENT PRESENTED TO THE EMERGENCY ROOM BECAUSE OF SYMPTOMS OF SYNCOPE HOWEVER NO LOSS OF CONSCIOUSNESS REPORTED. DURING DEVICE EVALUATION IT WAS FOUND THAT THE PATIENT STATED THE AUTOMATIC CAPTURE (AC) WAS TURNED ON IN A PREVIOUS CLINIC VISIT, CALLER ALLEGED IT WAS WORKING AT THE TIME. A LOSS OF CAPTURE (LOC) WAS NOTED ON TELEMETRY PREVIOUSLY. PATIENT IS DEPENDENT AND RECENTLY HAD AN AVN ABLATION. PACING AT THAT TIME SHOWED 100% CAPTURE. NOISE COULD BE REPRODUCED. THRESHOLDS HAVE BEEN HISTORICALLY HIGH. IMPEDANCES WERE STABLE. SENSITIVITY WAS ADJUSTED. THE DEVICE LONGEVITY REMAINING WAS FLUCTUATING AT THE TIME OF THE DEVICE EVALUATION. A SAVE TO DISC WAS PERFORMED AND SENT IN FOR ANALYSIS REVIEW BY BOSTON SCIENTIFIC TECHNICAL SERVICES (TS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309203 SWEET PICOTIP IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4055

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR S601| 1270| 4054| 4055