BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 1921636 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12623
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    September 9, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S039
    Removal / Correction Number
    ASKU
    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): BLOOD IN/ON HELIX/LOBE MECHANISM, HELIX DISTORTED/BENT, LEAD DAMAGED AT IMPLANT, AND BLOOD NOTED ON HELIX MECHANISM AND HELIX MECHANISM (SLEEVE HEAD); BLOOD AND TISSUE WERE VISIBLE ON THE HELIX; FULL LEAD RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE ATTEMPTING TO POSITION THE LEAD APPROXIMATELY 5 TIMES THAT THE SENSING AMPLITUDE DEGRADED AND IT WAS DIFFICULT TO EXTEND AND RETRACT THE HELIX. IT WAS ALSO NOTED THAT THERE WAS TISSUE AT THE TIP OF THE LEAD. THE LEAD WAS 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 S IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6935 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other