BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2951448 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00101
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    October 8, 2012
    Report Date
    February 5, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY #EVALUATION SUMMARY: THE LEAD WAS RETURNED AND ANALYZED. PRIMARY ANALYSIS REVEALED THAT THE OUTER INSULATION AND OVERLAY TUBING WERE BREACHED CUT AND BLOOD WAS PRESENT ON THE OVERLAY TUBING. VISUAL ANALYSIS INDICATED THAT THE LEAD WAS DAMAGED AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE LEAD WAS NOT IMPLANTED DUE TO A POSSIBLE INSULATION DEFECT. A NEW LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE LEAD WAS NOT IMPLANTED DUE TO A POSSIBLE INSULATION DEFECT. A NEW LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56999 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693565

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR (B)(4) BI-VENTRICULAR DEFIBRILLATOR