BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 3

    MDR report key: 1945844 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-21615
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    October 11, 2009
    Report Date
    November 7, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    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 THE PATIENT STATED SHE HAS EXPERIENCED SEVERE MUSCLE STIMULATION FOR THE PAST YEAR THAT HAS AFFECTED HER BREATHING ENOUGH THAT SHE NOW HAS AN INHALER. THE PATIENT STATED THAT SHE HAD RECENTLY BEEN TO THE CLINIC WHERE THE PHYSICIAN AND BOSTON SCIENTIFIC SALES REPRESENTATIVE (SR) ATTEMPTED TO ADJUST THE SETTINGS ON THE LEFT VENTRICULAR (LV) LEAD, WITH NO SUCCESS. THE PATIENT ALSO ALLEGED THAT HER PHYSICIAN HAS STATED THE MUSCLE STIMULATION COULD BE CAUSED BY A POSSIBLE LV LEAD DISLODGEMENT. THE SR WAS CONTACTED IN AN ATTEMPT TO OBTAIN ADDITIONAL INFORMATION AND RESOLUTION TO THIS EVENT. THE LEAD REMAINS IMPLANTED IN THE PATIENT. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AND THE INVESTIGATION IS NOW COMPLETE.

    Description of Event or Problem · 1

    THE BOSTON SCIENTIFIC SALES REPRESENTATIVE STATED THAT THE PATIENT HAS MADE SEVERAL CLINIC VISITS AND THE INTERROGATION SHOWS NO ISSUES, THUS NO PROGRAMMING CHANGES ARE MADE. THERE WAS ONE TIME WHERE MUSCLE STIMULATION WAS NOTED AND THE OUTPUT WAS MODIFIED. THE (B)(6) DID STATE THAT THE PATIENT HAD RECENTLY MOVED AND SHE IS UNAWARE OF THIS INSTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 3 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4524

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR MISMATCH| (B)(4)| (B)(4)| (B)(4)| (B)(4)