BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3071666 · Received April 22, 2013

    Report

    Report Number
    2649622-2013-05251
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 TO 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. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. PRODUCT ID: (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IMPLANTED: 2013 (B)(6). (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 IT WAS REPORTED THAT DURING IMPLANT THE RIGHT VENTRICULAR (RV) LEAD HAD NO SENSING AND NOISE. THE RV LEAD HELIX WAS RETRACTED AND EXTRACTED TO REMOVE "TISSUE" ATTACHING TO IT AND THE PROBLEM WAS RESOLVED. IT WAS ALSO REPORTED THAT THE RV LEAD HAD HIGH SHOCK COIL IMPEDANCE AND THE DEFIBRILLATION THRESHOLD TESTING FAILED AND AN EXTERNAL DEFIBRILLATOR WAS USED. THE POCKET WAS OPENED AND NO LOOSE PIN WAS CONFIRMED. IT WAS NOTED THAT THE NEW IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS WRAPPED DUE TO A PATIENT ALLERGY AND THE MOISTURE IN THE POCKET WAS DRAINED WHEN SUTURING. THE POCKET WAS REFILLED WITH FLUID AND THE IMPEDANCE MEASUREMENT RETURNED TO NORMAL. ANOTHER DEFIBRILLATION TEST FAILED AND THE LEAD WAS REPROGRAMMED AND THE TEST WAS SUCCESSFUL. THE RV LEAD AND ICD REMAINS IN USE. IT WAS LATER REPORTED THAT IT WAS CONCLUDED THAT THE ISSUES WITH THE DEVICE AND LEAD WERE DUE TO TISSUE ENTANGLEMENT, NOT A PRODUCT FAILURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED IT WAS REPORTED THAT DURING IMPLANT THE RIGHT VENTRICULAR (RV) LEAD HAD NO SENSING AND NOISE. THE RV LEAD HELIX WAS RETRACTED AND EXTRACTED TO REMOVE "TISSUE" ATTACHING TO IT AND THE PROBLEM WAS RESOLVED. IT WAS ALSO REPORTED THAT THE RV LEAD HAD HIGH SHOCK COIL IMPEDANCE AND THE DEFIBRILLATION THRESHOLD TESTING FAILED AND AN EXTERNAL DEFIBRILLATOR WAS USED. THE POCKET WAS OPENED AND NO LOOSE PIN WAS CONFIRMED. IT WAS NOTED THAT THE NEW IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS WRAPPED DUE TO A PATIENT ALLERGY AND THE MOISTURE IN THE POCKET WAS DRAINED WHEN SUTURING. THE POCKET WAS REFILLED WITH FLUID AND THE IMPEDANCE MEASUREMENT RETURNED TO NORMAL. ANOTHER DEFIBRILLATION TEST FAILED AND THE LEAD WAS REPROGRAMMED AND THE TEST WAS SUCCESSFUL. THE RV LEAD AND ICD REMAINS IN USE. ADDITIONAL INFORMATION WAS ATTEMPTED TO BE OBTAINED BUT WAS NOT AVAILABLE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171801 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M55

    Patients

    Seq Age Sex Outcome Treatment
    1 00031 YR Required Intervention