BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWEET PICOTIP

    MDR report key: 2905446 · Received January 9, 2013

    Report

    Report Number
    2124215-2012-13737
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    September 28, 2012
    Report Date
    October 8, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    RESOLUTION HAS BEEN REQUESTED FROM THE FIELD WHO LATER REPORTED THAT THE PATIENT HAD PRESENTED THE EMERGENCY ROOM AS THE NURSING HOME ATTENDANTS NOTICED A LOW BLOOD PRESSURE. THE PATIENT WAS SCHEDULED FOR A REVISION, BUT THIS WAS POSTPONED AS THE PATIENT HAD EATEN. THE DEVICE WAS REPROGRAMMED TO ELECTRO-CAUTERY MODE TO PREVENT THE INHIBITION OF PACING. THE PHYSICIAN'S PLAN WAS TO DOWNGRADE THE SYSTEM DUE TO INCREASED EJECTION FRACTION AND NO PAST TACHY THERAPIES. ANY EXPLANTED PRODUCTS WERE EXPECTED TO BE RETURNED.

    Additional Manufacturer Narrative · 1

    IT WAS LATER REPORTED THAT DURING THE REVISION PROCEDURE WHEN THE PHYSICIAN TOOK THE DEVICE OUT OF THE POCKET THE LEFT VENTRICULAR (LV) LEAD SETSCREW DID NOT APPEAR TO BE COMPLETELY TIGHTENED. THERE WAS INQUIRY IF THIS COULD IMPACT THE SENSING ON THE RV LEAD. TECHNICAL SERVICES DISCUSSED. THE LV LEAD CHECKED OUT FINE WITH GOOD IMPEDANCE AND NO NOISE. ULTIMATELY, THE RATE/SENSE PORTION OF THE RV LEAD WAS CAPPED AND USED THE RATE/SENSE PORTION OF THE 0157 LEAD.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT PRESENTED TO THE EMERGENCY ROOM. ON THE SURFACE AS WITH NO QRS, NO PACING, AND NO INTRINSIC NOTED FOR 2-3 SECONDS. HOWEVER, ON THE REAL TIME STRIP RVS MARKERS WERE NOTED. OVERSENSING WAS ALLEGED. DAILY MEASUREMENTS WERE REPORTED TO BE NORMAL. SENSITIVITY WAS CHANGED TO ADDRESS LOW RV AMPLITUDES AND THE REPROGRAMMING SEEMED TO HELP SOMEWHAT. THIS PATIENT WAS DEVICE DEPENDENT AND IT WAS UNKNOWN IF THE PATIENT HAD BEEN SYMPTOMATIC OR WHY THEY PRESENTED TO THE EMERGENCY ROOM. TECHNICAL SERVICES DISCUSSED TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11858 SWEET PICOTIP IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4055

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Hospitalization| L| R 4055| 4054| 4512| H135| 1280| 0157| H175