BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2130711 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10215
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    March 22, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    Z-0475-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 FOR (B)(4): THE FULL LEAD WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. THE DEFIBRILLATOR CONDUCTOR WAS DISTORTED AND THE INNER TUBING WAS KINKED/BUCKLED. THERE WAS BLOOD IN/ON THE HELIX MECHANISM AND SLEEVE HEAD. THERE WAS ALSO APPARENT EXPLANT DAMAGE. EVALUATION SUMMARY FOR (B)(4): THE FULL LEAD WAS RETURNED AND ANALYZED AND THE HELIX WAS DISENGAGED FROM THE HELICAL CHANNEL. THE DEFIBRILLATOR CONDUCTOR WAS DISTORTED AND THERE WAS BLOOD IN/ON THE HELIX MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT, THE RIGHT VENTRICULAR (RV) LEAD DISLODGED AND WAS REPOSITIONED. IT WAS FURTHER REPORTED THAT A WEEK AFTER THE INITIAL IMPLANT THE PATIENT RECEIVED A SHOCK FOR ATRIAL FIBRILLATION WITH A RATE TOO FAST FOR WAVELET. APPROXIMATELY TWO DAYS AFTER THE SHOCK, A CAREALERT SHOWED HIGH SENSING INTEGRITY COUNTERS, NON-SUSTAINED VENTRICULAR TACHYCARDIA, AND DECREASED R WAVES DUE TO THE RV LEAD DISLODGING FOR A SECOND TIME. DURING THE REPOSITIONING PROCEDURE, IT WAS DISCOVERED THAT THE RV LEAD HAD COILED IN THE POCKET AND THERE WAS TISSUE ON THE HELIX. THE LEAD WAS REMOVED. A NEW LEAD WAS ATTEMPTED TO BE IMPLANTED BUT THE LEAD DISLODGED DURING THE IMPLANT PROCEDURE. THE LEAD WAS REMOVED FROM THE PATIENT AND THE HELIX WOULD STILL NOT EXTEND. THE LEAD WAS REMOVED AND REPLACED. IT WAS LATER REPORTED THAT THE ATRIAL LEAD DISLODGED. THE STATUS OF THE ATRIAL LEAD IS UNKNOWN. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT QUATTRO SECURE IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R 6947 IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB