BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2051044 · Received April 12, 2011

    Report

    Report Number
    2649622-2011-05475
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    January 19, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. THE LEAD IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY FOR (B)(4): HELIX DISENGAGED FROM HELICAL CHANNEL. FULL LEAD RETURNED AND ANALYZED. ADDITIONAL OBSERVATIONS OF INNER TUBING KINKED/BUCKLED AND BLOOD IN/ON HELIX MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING IMPLANT OF THE RIGHT VENTRICULAR LEAD THE HELIX WAS DEPLOYED BUT MEASUREMENTS WERE NOT OPTIMAL. UPON REPOSITIONING, THE HELIX WOULD NOT DEPLOY. THE LEAD WAS NOT USED AND A NEW LEAD IMPLANTED. 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 62 YR Other 4076 IMPLANTABLE PACING LEAD