BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1862977 · Received October 9, 2010

    Report

    Report Number
    2649622-2010-10604
    Event Type
    Injury
    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; THE HELIX WILL NOT EXTEND OR RETRACT DUE TO DISTAL CONDUCTOR DISTORTION WITHIN THE CONNECTOR; BLOOD/BODY FLUID WAS PRESENT ON THE DISTAL CONDUCTOR AND IN/ON THE HELIX MECHANISM; LEAD WAS DAMAGED AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD SHOWED SMALL R-WAVES AND HIGH PACING THRESHOLD WITH IMPEDANCE IN THE 300'S. IT WAS SUSPECTED MICRO-DISLODGEMENT. DURING LEAD REPOSITIONING, THE PHYSICIAN WAS UNABLE TO EXTEND THE HELIX AFTER IT HAD BEEN RETRACTED. AFTER A FEW ATTEMPTS, THE LEAD WAS EXPLANTED AND 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 82 YR Required Intervention (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB