BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3050046 · Received April 10, 2013

    Report

    Report Number
    2124215-2013-03605
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    February 2, 2012
    Report Date
    August 11, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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). THE ICD REMAINS IMPLANTED AND IN SERVICE. 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). AT THIS TIME, THE LEAD AND DEVICE REMAIN IMPLANTED AND IN SERVICE. ONCE ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE SYSTEM DISPLAYED A HISTORY OF SHOCK IMPEDANCE MEASUREMENTS OF 100 OHMS TO 110 OHMS. THE PATIENT WITH THIS SYSTEM WAS BROUGHT IN FOR DEFIBRILLATION THRESHOLD (DFT) TESTING, WHICH WAS SUCCESSFUL AT 21J. AT THAT TIME, THE PHYSICIAN DID NOT SCHEDULE ADDITIONAL TESTING OR INTERVENTIONAL PROCEDURES. APPROXIMATELY ONE YEAR LATER, THE SHOCK IMPEDANCE MEASUREMENTS WAS OBSERVED TO BE GREATER THAN 125 OHMS. THE PHYSICIAN WAS TO REVIEW. NO FURTHER INFORMATION WAS AVAILABLE. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS REPORTED THAT A REVISION WAS PERFORMED AND THE RV LEAD WAS CAPPED AND SUCCESSFULLY REPLACED WITH A NON-BOSTON SCIENTIFIC PRODUCT. DURING THE PROCEDURE, IT WAS NOTED THAT THERE WAS SOME INDICATIONS OF RUBBING AND CUTS IN THE LEAD'S INSULATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED THAT DURING AN INTERROGATION OF THE DEVICE, A FAULT CODE INDICATING A SHOCK IMPEDANCE MEASUREMENT ABOVE 125 OHMS WAS DETECTED DURING SHOCK DELIVERY. THE SHOCK IMPEDANCE MEASUREMENTS WERE TESTED AND THE MEASUREMENTS WERE 104 OHMS. THE EPISODE DATA WAS SENT TO BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) FOR FURTHER REVIEW. A TS CONSULTANT DISCUSSED THAT THE PATIENT HAD A SUPRAVENTRICULAR TACHYCARDIA (SVT) WHERE BOTH ANTI-TACHYCARDIA PACING (ATP) AND SHOCKS WERE DELIVERED. THE SECOND SHOCK, A FULL ENERGY SHOCK, IS WHEN THE 125 OHMS MEASUREMENT WAS DETECTED. IT WAS ALSO NOTED THAT THERE WAS SOME NOISE ON THE ATRIAL AND VENTRICULAR CHANNELS AS WELL AS THE PACING IMPEDANCE MEASUREMENTS HAVE INTERMITTENTLY INCREASED BUT NOT GONE OUT OF RANGE. THE TS CONSULTANT DISCUSSED THAT THERE APPEARS TO BE AN ISSUE WITH THE LEAD AND REPLACEMENT OF THE LEAD AND DEVICE SHOULD BE CONSIDERED. THE FIELD REPRESENTATIVE WAS GOING TO COMMUNICATE THIS TO THE PHYSICIAN. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153193 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| L| R 0184| E110| 4469| T165