BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2813138 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16242
    Event Type
    Injury
    Date Received
    October 31, 2012
    Report Date
    November 8, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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. EVALUATION SUMMARY: (B)(4) THE DISTAL PORTION OF THE LEAD WAS RETURNED, ANALYZED AND THE DEFIBRILLATION COIL WAS DISTORTED. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED), THERE WAS BLOOD/BODY FLUID ON SEVERAL CONDUCTORS (NOT OBSTRUCTED), THE DEFIBRILLATOR CONDUCTOR WAS MELTED, THERE WAS BLOOD/BODY FLUID ON THE OUTER TUBING OVERLAY, THE OUTER TUBING OVERLAY MELTED, THE INNER TUBING WAS TORN, THE OUTER INSULATION WAS TORN, THE OUTER INSULATION WAS BREACHED CUT, THERE WAS A WHITE SUBSTANCE ON THE EXPOSED DEFIBRILLATION COIL, THE OUTER OVERLAY TUBING HAD A WHITE SUBSTANCE, THE HELIX/LOBE WAS DISTORTED/BENT, THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND THERE WAS APPARENT EXPLANT DAMAGE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) THE DISTAL PORTION OF THE LEAD WAS RETURNED, ANALYZED AND THE DEFIBRILLATION COIL WAS DISTORTED. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED), THERE WAS BLOOD/BODY FLUID ON SEVERAL CONDUCTORS (NOT OBSTRUCTED), THE DEFIBRILLATOR CONDUCTOR WAS MELTED, THERE WAS BLOOD/BODY FLUID ON THE OUTER TUBING OVERLAY, THE OUTER TUBING OVERLAY MELTED, THE INNER TUBING WAS TORN, THE OUTER INSULATION WAS TORN, THE OUTER INSULATION WAS BREACHED CUT, THERE WAS A WHITE SUBSTANCE ON THE EXPOSED DEFIBRILLATION COIL, THE OUTER OVERLAY TUBING HAD A WHITE SUBSTANCE, THE HELIX/LOBE WAS DISTORTED/BENT, THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND THERE WAS APPARENT EXPLANT DAMAGE. CONTINUED: 3830 IMPLANTABLE PACING LEAD - (B)(6) 2009, (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB - (B)(6) 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD INAPPROPRIATE SHOCKS DUE TO NOISE ON THE RIGHT VENTRICULAR (RV) LEAD. THE LEAD WAS CAPPED AND REPLACED AFTER AN UNSUCCESSFUL EXTRACTION ATTEMPT. IT WAS FURTHER REPORTED THAT THE LEAD EXTRACTION LATER OCCURRED DURING AN ATRIAL LEAD REPLACEMENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD INAPPROPRIATE SHOCKS DUE TO NOISE ON THE RIGHT VENTRICULAR (RV) LEAD. THE LEAD WAS CAPPED AND REPLACED AFTER AN UNSUCCESSFUL EXTRACTION ATTEMPT. IT WAS FURTHER REPORTED THAT THE LEAD EXTRACTION LATER OCCURRED DURING AN ATRIAL LEAD REPLACEMENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6947

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| L| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) COMPETITOR IMPLANTABLE PACING LEAD| 3830 IMPLANTABLE PACING LEAD