BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVISA DR MRI SURESCAN

    MDR report key: 3992660 · Received August 8, 2014

    Report

    Report Number
    9614453-2014-01961
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 27, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. THIS EVENT OCCURRED OUTSIDE THE US AND PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. CONCOMITANT PRODUCT: 5076-52 LEAD, IMPLANTED: (B)(6) 2014. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS OF THE DEVICE MEMORY WAS PERFORMED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT ATTEMPT OF AN IMPLANTABLE PULSE GENERATOR (IPG), THE TECHNICIAN NOTED INHIBITION OF PACING AND VENTRICULAR OVERSENSING DUE TO ARTIFACTS, WHICH WERE ONLY VISIBLE ON THE BIPOLAR CHANNEL BUT NOT THE UNIPOLAR CHANNEL. MANIPULATION OF THE POCKET SHOWED THE CAUSE OF THE ARTIFACTS WAS VENTRICULAR TACHYCARDIA (VT) - LIKE MORPHOLOGY. LEAD MEASUREMENTS WERE THEN TAKEN VIA THE PROGRAMMER, SHOWING VARYING MEASUREMENTS BETWEEN BIPOLAR AND UNIPOLAR. THE PACEMAKER WAS REMOVED AND THE LEAD PINS WERE CHECKED WITH NO PROBLEMS NOTED. THE LEADS WERE DISCONNECTED AND MEASURED AGAIN, SHOWING ACCEPTABLE R WAVES BUT LOWER P WAVES. THE THRESHOLDS AND IMPEDANCES WERE IN RANGE. A CONTACT ISSUE BETWEEN THE LEADS AND HEADER WAS SUSPECTED, SO THE PHYSICIAN ENSURED THE PINS WERE FULLY INSERTED AND THE SETSCREW COMPLETELY TIGHTENED. AS THE POCKET WAS BEING SOWN BACK UP, THE SAME ARTIFACTS AS BEFORE WERE SEEN ON THE ELECTROGRAM. THE PHYSICIAN ELECTED TO CONNECT THE LEADS TO A DIFFERENT IPG DUE TO THE VARYING R WAVES AND P WAVES. NO ARTIFACTS WERE NOTED WITH THE SECOND IPG, AND THE MEASUREMENTS WERE WITHIN RANGE. THE DEVICE WAS THEREFORE REPLACED, WHILE THE LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471026 ADVISA DR MRI SURESCAN PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND A3DR01

    Patients

    Seq Age Sex Outcome Treatment
    1 5076-58 LEAD