BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3062204 · Received April 16, 2013

    Report

    Report Number
    2649622-2013-05079
    Event Type
    Injury
    Date Received
    April 16, 2013
    Report Date
    April 25, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THE DISTAL CONDUCTOR OF THE LEAD DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS ADMITTED TO THE HOSPITAL AFTER RECEIVING AN INAPPROPRIATE SHOCK DUE TO LEAD OVERSENSING. THE LEAD ALERT TRIGGERED DUE TO HIGH IMPEDANCE. A LEAD FRACTURE WAS CONFIRMED ON X-RAY. THE LEAD WAS PARTIALLY REMOVED AND REPLACED. DURING THE LEAD IMPLANT ATTEMPT, IT WAS NOT POSSIBLE TO IMPLANT THE LEAD ON THE LEFT SIDE DUE TO LACK OF VENOUS ACCESS. A LONGER LEAD WAS IMPLANTED THE FOLLOWING DAY ON THE RIGHT SIDE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162125 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693565

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Hospitalization| L| R