BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2790088 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14103
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    July 25, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    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. EVALUATION SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED, AND THE HELIX WAS DISTORTED/BENT. IT WAS ALSO NOTED THAT THERE WAS BLOOD IN/ON THE HELIX MECHANISM AND SLEEVEHEAD, THE TURNS TO EXTEND/RETRACT THE HELIX EXCEEDS SPECIFICATION, AND THE LEAD WAS DAMAGED AT IMPLANT. THE ANALYST NOTED THAT THE LEAD WAS RECEIVED WITH THE HELIX EXTENDED, STRETCHED, AND BENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE DAY POST IMPLANT, THE LEAD HAD NO CAPTURE AND WAS DISLODGED. DURING THE LEAD REVISION, IT WAS NOT POSSIBLE TO SCREW THE LEAD INTO THE MYOCARDIUM. THE LEAD WAS 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
    1 SPRINT QUATTRO SECURE IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6947

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R