BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2790529 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-15343
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    August 27, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    NVY
    PMA / PMN Number
    P920015/S055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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, ANALYZED, AND THE HELIX WAS DISTORTED/BENT. IT WAS ALSO NOTED THAT THERE WAS BLOOD IN/ON THE HELIX MECHANISM, THE TURNS TO EXTEND/RETRACT THE HELIX EXCEEDS SPECIFICATION, AND THE LEAD WAS DAMAGED AT IMPLANT. IT WAS ALSO NOTED THAT THE LEAD WAS RETURNED WITH THE HELIX EXTENDED, BENT, COMPRESSED AND CANTED, AND BLOOD WAS VISIBLE ON THE HELIX.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THERE WAS DIFFICULTY EXTENDING THE HELIX. THE LEAD WAS REMOVED AND ANOTHER LEAD WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE NOTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT QUATTRO SECURE IMPLANTABLE TACHY LEAD NVY MEDTRONIC PUERTO RICO, INC. 6947M

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other