BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2123520 · Received June 14, 2011

    Report

    Report Number
    2649622-2011-07975
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    March 2, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    Z-0475-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 FULL LEAD WAS RETURNED FOR ANALYSIS. NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE HELIX/LOBE WAS DISTORTED AND BENT. THE HELIX WAS STRETCHED DURING ANALYSIS. THERE WAS ALSO BLOOD IN AND ON THE HELIX/LOBE MECHANISM. THE STYLET WAS STUCK IN THE LEAD DISTAL COIL, SO THE LEAD INSULATION WAS PUNCTURED WITH A SYRINGE TO INJECT ALCOHOL IN AN ATTEMPT TO REMOVE THE STYLET FROM THE DISTAL COIL WHICH WAS STUCK DUE TO DRIED BLOOD. THE ATTEMPT WAS NOT SUCCESSFUL, AND THE STYLET COULD NOT BE REMOVED. IT ALSO APPEARED THAT THE LEAD WAS DAMAGED AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS PLACED DURING IMPLANT BUT HAD POOR SENSING AND CAPTURE. UPON REPOSITIONING, THE LEAD'S HELIX WOULD NOT DEPLOY. THE LEAD WAS REMOVED FROM THE BODY AND AN ATTEMPT TO DEPLOY THE HELIX ON THE TABLE WAS SUCCESSFUL. THE LEAD WAS REPLACED WITH ANOTHER LEAD. 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other 5076 IMPLANTABLE PACING LEAD