BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 3790175 · Received May 5, 2014

    Report

    Report Number
    2124215-2014-10003
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    March 25, 2013
    Report Date
    June 6, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE RIGHT VENTRICULAR (RV) LEAD AND DEFIBRILLATOR EXHIBITED SEVERAL HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. THE CLINICIAN CONTACTED BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) AND NOTED THAT ALL OTHER MEASUREMENTS WERE WITHIN RANGE AND STABLE. TS DISCUSSED THE OPTION OF BRINGING THE PATIENT IN FOR EVALUATION AND ISOMETRICS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE AND LEAD REMAIN IMPLANTED IN THE PATIENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A MEDICAL PERSONNEL THAT ALONG WITH CONTINUED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS THE PATIENT IS NOW REPORTING HEARING TONES. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND IT WAS DISCOVERED THAT THE PATIENT IS WEARING A NECKLACE THAT HAS A MAGNET. TS DISCUSSED THAT MAGNET APPLICATION CAN CAUSE THE DEVICE TO EMIT TONES. TS ALSO NOTED THAT THEY SHOULD BRING THE PATIENT IN FOR EVALUATION TO RULE OUT ANY OTHER POSSIBLE REASONS FOR THE TONES. THE FIELD REPRESENTATIVE WILL ATTEMPT TO OBTAIN ADDITIONAL INFORMATION FROM THE CLINIC. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS BROUGHT INTO THE OFFICE WHERE IT WAS CONFIRMED THAT THE TONES WERE FROM THE DEVICE AND BEING CAUSED BY THE MAGNET IN THE PATIENT'S NECKLACE. INTERROGATION DID NOT REVEAL ANY FURTHER ISSUES AND NO PACING INHIBITION WAS NOTED. THE PATIENT WAS ADVISED NOT TO WEAR THE NECKLACE. THE DEVICE REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267604 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND N141

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR 4469| H170| N141| 0147| 1296| 4542