BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2124215-2011-00966

    MDR report key: 1962289 · Received January 18, 2011

    Report

    Report Number
    2124215-2011-00966
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    December 28, 2010
    Report Date
    December 28, 2010
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD REMAINS IMPLANTED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACING SYSTEM ANALYZER (PSA) WAS HOOKED UP TO THIS RIGHT VENTRICULAR LEAD DURING THE ABLATION PROCEDURE. DURING THE PROCEDURE THE PSA WAS PROGRAMMED TO VVI AND VOO 40 AND IT WAS NOTED THAT THE LEAD WAS NOT PACING. TECHNICAL SERVICES WAS CONTACTED AND SUSPECTED A CABLE ISSUE. THE FIELD REPRESENTATIVE REPORTED LATER THAT THE PHYSICIAN HAD THE PSA HOOKED UP TO THE WRONG LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE REPRESENTATIVE COULD NOT PROVIDE SPECIFIC MODEL AND SERIAL NUMBERS AS SHE WAS ONLY IN THE AREA AND NOT IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NVN GUIDANT PUERTO RICO BV BRADY LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1