BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWEET TIP

    MDR report key: 2040079 · Received April 5, 2011

    Report

    Report Number
    2124215-2011-01011
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 4, 2011
    Manufacturer
    HISTORICAL PUERTO RICO
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT SUSPECTS THAT OVERSENSING OCCURRED AS A RESULT OF THE POWER SOURCE FOR THE HARMONIC DEVICE OR DUE TO SOMETHING ELSE. THE CONSULTANT INSTRUCTED THE CALLER TO CHECK THE ARRYTHMIA LOGBOOK TO CONFIRM ANY STORED EPISODES THAT EXHIBITED OVERSENSING. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT HAD UNDERGONE A LAPAROSCOPIC HERNIA REPAIR TODAY. THE DEVICE WAS PROGRAMMED AAIR AND ELECTROCAUTERY WAS NOT UTILIZED FOR THE PROCEDURE. HOWEVER, A HARMONIC DEVICE WAS USED DURING THE PROCEDURE. THE PHYSICIAN STATED THAT HE THOUGHT THE DEVICE WAS PROGRAMMED TO 70PPM BUT A RATE OF 30 WAS OBSERVED DURING THE PROCEDURE. A MAGNET WAS APPLIED TO THE PACEMAKER WHICH BROUGHT THE PACING RATE BACK UP. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWEET TIP IMPLANTABLE LEAD NVN HISTORICAL PUERTO RICO 4269

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR 1194| 4269| (B)(4)