BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1284137 · Received January 7, 2009

    Report

    Report Number
    2649622-2009-00194
    Event Type
    Injury
    Date Received
    January 7, 2009
    Date of Event
    September 26, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. 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: NO ANOMALIES FOUND; THERE WAS ONLY ONE SET OF SETSCREW MARKS ON THE IS-1 PIN AND IT IS TOO PROXIMAL, INDICATING THE LEAD WAS NOT FULLY INSERTED INTO THE DEVICE; FULL LEAD RETURNED AND ANALYZED. OTHER: IT WAS REPORTED THAT DURING A FOLLOW-UP CHECK, THE LEAD IMPEDANCE WAS HIGH/VARIABLE, AT 520-3000 OHMS, AND LEAD FRACTURE WAS SUSPECTED. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED. ELECTRICAL TESTS PERFORMED; MECHANICAL TESTS PERFORMED. VISUAL EXAMINATION: DEVICE PERFORMED ACCORDING TO SPECIFICATIONS. OPERATIONAL CONTEXT CONTRIBUTED TO EVENT; IMPEDANCE, HIGH, LEAD(S), FRACTURE OF.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FOLLOW-UP CHECK, THE LEAD IMPEDANCE WAS HIGH/VARIABLE, AT 520-3000 OHMS, AND LEAD FRACTURE WAS SUSPECTED. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE 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