BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3921851 · Received July 9, 2014

    Report

    Report Number
    2124215-2014-12650
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    May 5, 2014
    Report Date
    November 25, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    P960040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURN OF THE PRODUCT WAS REQUESTED. 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). ADDITIONAL INFORMATION WAS RECEIVED THAT THE PRODUCT IS IN POSSESSION OF THE HOSPITAL AND IS NOT EXPECTED TO BE RETURNED. 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). UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION NOTED THAT THE HEADER WAS LOOSE. X-RAY EXAMINATION WAS PERFORMED. THE RV TIP AND RV RING HEADER WIRE(S) WERE FOUND TO BE FRACTURED. IMPROVEMENTS HAVE BEEN MADE TO THE MANUFACTURING PROCESS IN ORDER TO STRENGTHEN THE BOND BETWEEN THE HEADER AND THE DEVICE CASE. LABORATORY ANALYSIS CONFIRMED THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS ICD AND RV LEAD WERE EXPLANTED FOUR MONTHS LATER. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECEIVED AN INAPPROPRIATE SHOCK DUE TO A COMPROMISED RIGHT VENTRICULAR (RV) LEAD. THIS ICD AND RV LEAD EXHIBITED HIGH, OUT-OF-RANGE (OOR) PACING LEAD IMPEDANCE MEASUREMENT GREATER THAN 2,000 OHMS ALONG WITH OVERSENSING OF NOISE AND LOSS OF CAPTURE (LOC). SUBSEQUENTLY, THE DEVICE WAS PROGRAMMED TO MONITOR ONLY AND AN ALERT FOR OUT-OF-RANGE PACING LEAD IMPEDANCE WAS THEN DETECTED VIA THE PATIENT¿S REMOTE MONITORING SYSTEM. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT LOC DID NOT RESULT TO GREATER THAN 2 SECONDS OF ASYSTOLE AND SURGICAL INTERVENTION HAS NOT BEEN PERFORMED. A WEEK LATER, A RED ALERT FOR THE HIGH, OOR, SHOCK IMPEDANCE MEASUREMENT WAS DETECTED. AT THIS TIME, THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400512 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| L| R 5076| 0157| E110| A135