BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1862953 · Received October 9, 2010

    Report

    Report Number
    2649622-2010-10617
    Event Type
    Injury
    Date Received
    October 9, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS NOTIFIED BY AN ICD BASED LEAD INTEGRITY ALERT. IT WAS FURTHER REPORTED THAT WHEN THE ICD WAS CHECKED, THE LEAD IMPEDANCE WAS VARIABLE AND ICD BASED LEAD PERFORMANCE MEASUREMENTS INDICATED NON PHYSIOLOGIC SENSING. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT. IT WAS REPORTED THAT THE SYSTEM WILL BE REPLACED.

    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 58 YR Other SECURA DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB| CAPSURE FIX IMPLANTABLE PACING LEAD