BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 3905427 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-10636
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    May 6, 2014
    Report Date
    August 20, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    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). ADDITIONAL DETAILS ARE EXPECTED, THIS REPORT WILL BE UPDATED UPON RECEIPT OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATES THAT THE PATIENT AGAIN UNDERWENT SYSTEM INTEGRITY TESTING. THE LEAD WAS TESTED IN SEVERAL DIFFERENT CONFIGURATIONS. WHEN THE FLOATING COIL, SQ LEAD, WHICH IS A COMPETITOR'S PRODUCT, WAS INVOLVED THE MEASUREMENTS WERE OUT OF RANGE. HOWEVER, WITH ALL COILS AND CAN IN THE CIRCUIT THE COMMANDED 1.1 JOULE SHOCK RESULTED IN AN IMPEDANCE MEASUREMENT OF 70 OHMS AND THE COMMANDED 41 JOULE SHOCK RESULTED IN AN IMPEDANCE MEASUREMENT OF 71 OHMS. THE POST SHOCK PROGRAMMER IMPEDANCE MEASUREMENT WAS 86 OHMS, REPEATEDLY. THE LEADS AND CAN WERE SCREENED WITH NO OBVIOUS ABNORMALITIES REVEALED. AT THIS TIME, THIS SYSTEM REMAINS IMPLANTED AND NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. IT WAS REPORTED THAT THIS PATIENT HAS A NON-STANDARD SET-UP IN REGARDING TO THE SHOCKING VECTOR. THE PATIENT HAS A SINGLE COIL LEAD AND A FREE FLOATING SUBCUTANEOUS COIL MID-AXILLARY. THE SHOCK VECTOR IMPEDANCE RANGE FROM 85 OHMS TO 100 OHMS WITH INSPIRATION AND COIL TO COIL IMPEDANCES WERE 155 OHMS. IT WAS BELIEVED THAT THE HIGH MEASUREMENTS WERE TAKEN AT POINTS OF MAXIMAL INSPIRATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT REMAINS IN-SERVICE. THE SPECIFICS ON THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD HAS NOT BEEN PROVIDED. THE PHYSICIAN PLANS TO CONTINUE TO MONITOR THIS PATIENT THROUGH THE REMOTE HOME MONITORING SYSTEM.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED THAT THE PHYSICIAN FEELS THAT TACHYCARDIA THERAPY IS STILL AVAILABLE FOR THIS PATIENT AND NO FURTHER TESTING WILL BE PERFORMED. THE PHYSICIAN PLANS TO CONTINUE TO MONITOR THIS SITUATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATES THAT THIS SYSTEM CONTINUES TO EXHIBIT INTERMITTENT HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. ADDITIONALLY, IT WAS REPORTED THAT THIS PATIENT PREVIOUSLY UNDERWENT DEFIBRILLATION THRESHOLD (DFT) TESTING DUE TO HIGH IMPEDANCE MEASUREMENTS. AT THAT TIME, THE PHYSICIAN OPTED TO CONTINUE TO MONITOR THE PATIENT. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REVIEWED THE CASE AND PROVIDED POSSIBLE CAUSES AND TROUBLESHOOTING OPTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383133 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F143

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR F143