BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 4160999 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11685
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 8, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE A SIMILAR MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. THE DISTAL LV (LOW VOLTAGE) ELECTRODE OF THE LEAD WAS COVERED IN BLOOD, ALL ELECTRICAL TESTING WAS WITHIN SPECIFIED PARAMETERS. THE LEAD SHOWED SIGNS OF BEING TWISTED IN-VIVO, INCLUDING A BREACH OF THE OVERLAY TUBING. BLOOD INGRESS WAS NOT OBSERVED AND A BREACH OF THE OUTER INSULATION WAS NOT OBSERVED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS. THE RIGHT VENTRICULAR LEAD HAD OVERSENSING, NOISE, AND VERY LOW IMPEDANCE ON THE PACE/SENSE COIL. THE LEAD WAS REPLACED BUT THE IMPEDANCE REMAINED VERY LOW. BECAUSE THERE WAS NO CHANGE IN IMPEDANCE THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS ALSO EXPLANTED AND REPLACED. IT IS UNCLEAR IF IT WAS A LEAD ISSUE, DEVICE ISSUE OR BOTH. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641149 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693565

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Hospitalization| L| R D394VRG ICD