BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1072281 · Received July 10, 2008

    Report

    Report Number
    2649622-2008-03918
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    May 30, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    Reporter Occupation
    INVALID DATA

    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: BLOOD IN/ON HELIX/LOBE MECHANISM; FULL LEAD WAS RETURNED FOR ANALYSIS. THE LEAD WAS RETURNED WITH A LOT OF BLOOD IN AND ON THE HELIX AREA THAT MOST LIKELY PREVENTED THE HELIX FROM FUNCTIONING PROPERLY. THERE WERE NO ANOMALIES FOUND THAT WOULD CONTRIBUTE TO THE REPORTED ELECTRICAL ISSUES. IT WAS REPORTED THE LEAD HAD DISLODGED, WITH SENSING DIFFICULTY, FIXATION DIFFICULTY, HIGH THRESHOLDS, NO CAPTURE AND THERE WAS A PERFORATION. AT THE TIME OF LEAD REVISION ATTEMPT, THERE WAS DIFFICULTY EXTENDING/RETRACTING THE HELIX AND THE LEAD WAS REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED ELECTRICAL TESTS PERFORMED, MECHANICAL TESTS PERFORMED, VISUAL EXAMINATION COMPONENT/SUBASSEMBLY FAILURE LEAD CONDUCTOR OPERATIONAL CONTEXT CONTRIBUTED TO EVENT CAPTURE, FAILURE TO POSITIONING DIFFICULTIES SENSITIVITY HIGH THRESHOLD.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEAD HAD DISLODGED, WITH SENSING DIFFICULTY, FIXATION DIFFICULTY, HIGH THRESHOLDS, NO CAPTURE AND THERE WAS A PERFORATION. AT THE TIME OF LEAD REVISION ATTEMPT, THERE WAS DIFFICULTY EXTENDING/RETRACTING THE HELIX AND THE LEAD WAS REPLACED. NO FURTHER 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 Required Intervention 6947 IMPLANTABLE TACHY LEAD| D154VWC IMPLANTABLE PACEMAKER/CARDIO/DEFIB