BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 1854856 · Received October 5, 2010

    Report

    Report Number
    2649622-2010-09288
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    August 16, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S039
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. EVALUATION SUMMARY; (B)(4) THE FULL LEAD WAS RETURNED WHERE THE PROXIMAL CONDUCTOR WAS DISCOVERED TO BE FRACTURED. THERE WAS BLOOD/BODY FLUIDS ON THE OUTER TUBING OVERLAY AND IN/ON THE HELIX MECHANISM. THE OUTER TUBING OVERLAY WAS MELTED AND BREACHED CUT. THERE WAS COSMETIC DEPRESSION ON THE OUTER INSULATION.

    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. ANALYSIS OF THE LEAD IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    ASKU

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LIA (LEAD INTEGRITY ALERT) SOUNDED, AND THE PATIENT PRESENTED FOR AN UNSCHEDULED FOLLOW-UP VISIT. (B)(4) SHORT INTERVALS WERE NOTED, AND A LEAD FRACTURE WAS INDICATED. 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 S ASKU LWS MEDTRONIC PUERTO RICO, INC. 6935 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R 7230CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 7230CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB