BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1802888 · Received August 17, 2010

    Report

    Report Number
    2649622-2010-08773
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    June 25, 2010
    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
    LA, 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 ANALYZED. THE HELIX WILL NOT EXTEND DUE TO THE DISTORTED AND FRACTURED DISTAL COIL IN THE CONNECTOR. THIS IS CAUSED FROM OVER TURNING. BLOOD OBSERVED ON THE DISTAL CONDUCTOR AND IN/ON THE HELIX MECHANISM (SLEEVE HEAD).

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE LEAD IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DURING AN ATTEMPT TO IMPLANT THE PACING LEAD, THE HELIX WOULD NOT DEPLOY AND THAT, WHEN IT DID EXTEND, "IT TOOK TOO MANY TURNS (20+)." THE LEAD WAS NOT IMPLANTED. A NEW LEAD OF THE SAME MODEL WAS SUCCESSFULLY IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS 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 72 YR Other| R