BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3992961 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09571
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. CONCOMITANT MEDICAL PRODUCTS: 5076-52 LEAD, IMPLANTED: (B)(6) 2007. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE INTERIOR SVC (SUPERIOR VENA CAVA) DEFIBRILLATION CABLE DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO, AND THE OUTER INSULATION OF THE LEAD DEVELOPED A BREACH DUE TO A DEPRESSION WHILE IN VIVO; FULL LEAD IN SEGMENTS RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A CAREALERT DUE TO A SUDDEN RISE IN SVC (SUPERIOR VENA CAVA) DEFIBRILLATION COIL IMPEDANCE TO HIGH LEVELS. THE RV (RIGHT VENTRICULAR) DEFIBRILLATION COIL IMPEDANCE ALSO INCREASED. THE POCKET WAS REOPENED FOR FURTHER INVESTIGATION. THE PHYSICIAN PULLED ON THE SVC PIN CONNECTION, AND FOUND THE SVC PIN NOT SCREWED INTO THE HEADER. THE SVC COIL WAS TESTED VIA THE ANALYZER AND FOUND TO HAVE HIGH IMPEDANCE. VISIBLE DAMAGE AND TWISTING TO THE LEAD WERE NOTED JUST OUTSIDE THE HEADER PIN. THE PHYSICIAN BELIEVED THAT THIS FRACTURE WAS CAUSED SECONDARY TO THE SETSCREW FOR THE SVC COIL NOT BEING TIGHT. THE DEVICE AND LEAD WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467641 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694758

    Patients

    Seq Age Sex Outcome Treatment
    1 00022 YR Hospitalization| R D154AWG ICD