BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT

    MDR report key: 1792259 · Received August 10, 2010

    Report

    Report Number
    2649622-2010-07065
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S13
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 THE IMPEDANCE AND THRESHOLD OF THIS LEAD HAVE RISEN OVER TIME. THE LEAD IS CONNECTED TO ANOTHER MANUFACTURER'S PULSE GENERATOR. THIS IMPEDANCE/THRESHOLD WILL BE MONITORED. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE LEAD WAS SCHEDULED FOR REVISION (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6943 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention