BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCEPTA

    MDR report key: 3053101 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04657
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 14, 2013
    Report Date
    April 17, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN WILL CONTINUE TO MONITOR THE SYSTEM. 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

    THE SHOCKING VECTOR WAS REPROGRAMMED AND THE PHYSICIAN WAS PLANNING TO FOLLOW-UP WITH THE PATIENT IN THE NEAR FUTURE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THE LOCAL AREA FIELD REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE AND RECORDS INDICATE THESE PRODUCTS REMAIN IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE PATIENT WAS SEEN FOR FURTHER EVALUATION. THE POCKET WAS REOPENED TO ASSESS THE LEAD CONNECTIONS. A TUG TEST WAS PERFORMED AND THE CONNECTION WAS FOUND TO BE SECURE. ADDITIONALLY, ALL SET SCREWS WERE DOWN. THE HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS COULD NOT BE REPRODUCED WITH THE POCKET OPEN. THE SHOCKING VECTOR WAS AGAIN REPROGRAMMED AND DEFIBRILLATION THRESHOLD (DFT) TESTING WAS PERFORMED WITH A 21 JOULE SHOCK. THE IMPEDANCE MEASUREMENT WAS 67 OHMS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE PATIENT WAS SEEN IN CLINIC. UPON INTERROGATION THE SHOCK IMPEDANCE MEASUREMENT WAS IN THE HIGH 60 OHM RANGE. HIGH OUT OF RANGE MEASUREMENTS WERE REPRODUCED WITH POCKET MANIPULATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE DEFIBRILLATION LEAD AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED BRINGING THE PATIENT INTO CLINIC AND TROUBLESHOOTING OPTIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155943 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND N164

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L| R 0184| N164| H215| 4525| 4469