BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3043126 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-01885
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    January 24, 2013
    Report Date
    February 21, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF ADDITIONAL INFORMATION, THIS EVENT 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 DURING A FOLLOW UP VISIT, THIS IMPLANTABLE RIGHT VENTRICULAR (RV) LEAD AND CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED OVERSENSING. IT WAS THOUGHT THIS WAS DUE TO EXTERNAL ELECTROMAGNETIC INTERFERENCE (EMI). AS THE DEVICE IS CLOSE TO ELECTIVE REPLACEMENT INDICATOR (ERI), A REPLACEMENT PROCEDURE IS INTENDED IN THE NEAR FUTURE. ALL MEASUREMENTS WERE NORMAL AND NO INAPPROPRIATE SHOCKS HAD BEEN DELIVERED AS A RESULT OF THE OVERSENSING. AN INTERNAL TECHNICAL SERVICE CONSULTANT WAS CONTACTED. AFTER REVIEWING THE ELECTROGRAMS, IT WAS THOUGH THE HIGH VOLTAGE LEADS ARE REVERSED IN THE DEVICE HEADER. WHEN THE HIGH VOLTAGE LEADS ARE REVERSED, THE DEVICE IS SENSING BETWEEN DISTAL COIL/CAN AND PROXIMAL COIL AND MYOPOTENTIALS FROM THE PECTORAL MUSCLES MAY BE PICKED UP ON THE SHOCK CHANNELS AND AMPLIFIED. EMI COULD NOT BE RULED OUT. VERIFICATION OF THE CONNECTION WAS RECOMMENDED DURING THE REPLACEMENT PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. A REVISION PROCEDURE WAS PERFORMED. UPON OPENING THE POCKET, VISUAL OBSERVATION CONFIRMED THE LEADS WERE REVERSED IN THE DEVICE HEADER. THEY WERE DISCONNECTED AND RESEATED APPROPRIATELY IN THE REPLACEMENT DEVICE. NO ADVERSE PATIENT SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147554 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R