BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 1990749 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02117
    Event Type
    Injury
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S039
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED IN SEGMENTS, ANALYZED, AND THE DISTAL CONDUCTOR WAS FRACTURED. IT WAS ALSO NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE OUTER TUBING OVERLAY AND THE HELIX MECHANISM, THE INNER TUBING WAS KINKED/BUCKLED, THE OUTER TUBING OVERLAY WAS BREACHED CUT, THE EXPOSED DEFIBRILLATION COIL HAD A WHITE SUBSTANCE, AND THE OUTER INSULATION HAD A COSMETIC DEPRESSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CALLED THE CLINIC WITH THE LEAD INTEGRITY ALERT (LIA) RINGING EVERY FOUR HOURS. MEASUREMENTS AT FOLLOW-UP REVEALED HIGH IMPEDANCE, HIGH SHORT INTERVAL COUNTER (SIC) VALUE, TWENTY-EIGHT NON-SUSTAINED TACHYCARDIAS AND ONE VENTRICULAR FIBRILLATION EPISODE. THE DEVICE WAS REPROGRAMMED UNTIL THE LEAD WAS EXPLANTED AND REPLACED. 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 S IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6935 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 7304 IMPLANTABLE PACEMAKER/CARDIO/DEFIB