BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 4131712 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14772
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    September 2, 2010
    Report Date
    June 16, 2016
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    P960040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED INDICATES THAT THE NEWER RV LEAD ALSO HAS LOW OUT-OF-RANGE PACING IMPEDANCES ASSOCIATED WITH IT. THE PATIENT IS NOT PACEMAKER DEPENDENT. NO INTERVENTION WAS PERFORMED AND THE PATIENT WILL BE MONITORED.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED INDICATES THAT THIS ICD DETECTED HIGH OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS. THE DEVICE SYSTEM WAS ELECTRICALLY DEACTIVATED BUT REMAINS IMPLANTED. NO FURTHER INTERVENTION IS PLANNED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED INDICATES THAT THE LEAD REVISION PROCEDURE DID NOT RESOLVE THE OVERSENSING OF NOISE WHICH COULD NOT BE REPRODUCED WITH POCKET MANIPULATION. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) SUSPECTS THAT THE CAUSE OF THE OVERSENSED NOISE IS LIKELY A RESULT OF THE RV LEAD RATE/SENSE COIL TOUCHING THE EXPOSED DISTAL COIL OF THE FRACTURED RIGHT ATRIAL (RA) LEAD WHICH IS CURRENTLY IMPLANTED BUT ELECTRICALLY ABANDONED. THE DEVICE WAS REPROGRAMMED BUT THE NOISE WAS STILL OVERSENSED. THE DEVICE WAS AGAIN REPROGRAMMED AND APPEARS TO HAVE RESOLVED THE ISSUE. THE PATIENT WILL BE MONITORED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED LOW OUT OF RANGE PACING IMPEDANCES ON THE RIGHT VENTRICULAR (RV) LEAD AND HIGH OUT OF RANGE PACING IMPEDANCES ON THE RIGHT ATRIAL (RA) LEAD. THERE WAS ALSO NOISE, OVERSENSING AND INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) THERAPY DELIVERED. A LEAD REVISION PROCEDURE WAS PERFORMED. ALL AVAILABLE INFORMATION INDICATES THAT THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612644 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization| L| R E110| 4087