BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1863090 · Received October 9, 2010

    Report

    Report Number
    2649622-2010-10426
    Event Type
    Malfunction
    Date Received
    October 9, 2010
    Date of Event
    July 15, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    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 AND ANALYZED. ANALYSIS INDICATES THE HELIX WAS DISENGAGED FROM THE HELICAL CHANNEL. THE HELIX WOULD NOT EXTEND DUE TO BEING OVER RETRACTED. IT WAS ALSO NOTED THAT BLOOD WAS FOUND IN/ON THE HELIX/LOBE MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT IMPLANT THE LEAD HAD POOR SENSING AND HIGH PACING THRESHOLD IN SEVERAL POSITONS. WHEN THE PHYSICIAN MOVED THE LEAD TO ANOTHER POSITION THE HELIX WOULD NOT ADVANCE. AFTER SEVERAL ATTEMPTS, 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 IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention