BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3761318 · Received April 21, 2014

    Report

    Report Number
    2124215-2014-08731
    Event Type
    Injury
    Date Received
    April 21, 2014
    Date of Event
    March 14, 2014
    Report Date
    January 18, 2016
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE PRODUCT HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED, ANALYSIS WILL BE PERFORMED AND THIS REPORT WOULD BE UPDATED AT THAT TIME.

    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 THIS RIGHT VENTRICULAR (RV) LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED HIGH, OUT OF RANGE, SHOCK IMPEDANCE MEASUREMENT THAT WAS DETECTED VIA THE PATIENT'S REMOTE HOME MONITORING SYSTEM. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS TO DETERMINE THE CAUSE OF THE OBSERVATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. ALL AVAILABLE INFORMATION INDICATES THAT SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION RECEIVED THAT ANOTHER HIGH, OUT OF RANGE, SHOCK LEAD IMPEDANCE MEASUREMENT WAS DETECTED VIA PATIENT HOME MONITORING SYSTEM. THIS IS AN ONGOING ISSUE. TS RECOMMENDED TO HAVE PATIENT FURTHER EVALUATED. ADDITIONAL INFORMATION OBTAINED FROM THE FIELD REPRESENTATIVE INDICATES THAT CLINIC DID RECEIVED THE EPISODE AND STILL WAITING FOR THE PHYSICIAN TO SET AN APPOINTMENT. SYSTEM STILL REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH, OUT OF RANGE SHOCK IMPEDANCE (GREATER THAN 200 OHMS). THE PATIENT INDICATED THAT THEY DID NOT LIKE THE SIZE AND COMFORT OF THE DEVICE. THE PHYSICIAN CAPPED THE RV LEAD AND REPLACED THE ICD WITH A MINI ICD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239359 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L| R E110| 4086| T135