BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3904237 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-09560
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    March 27, 2014
    Report Date
    January 28, 2015
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-0026-2014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS CURRENTLY AVAILABLE, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEVICE HAD NOT YET BEEN REPLACED AS THE PATIENT HAD A MALFUNCTIONING DIALYSIS SHUNT OVER THE DEVICE IMPLANT SITE. THE DEVICE FOLLOWING PHYSICIAN DEVELOPED A PLAN THAT INCLUDED SURGICAL REPAIR AND MOVING OF THE SHUNT OFF OF THE DEVICE SITE. THE PATIENT THEN WILL CONTINUE TO BE MONITORED BY REMOTE MONITORING AND IF END OF LIFE (EOL) IS REACHED BY THE DEVICE, THEN THE PATIENT WILL WEAR A LIFEVEST. SIX WEEKS FOLLOWING THE SURGICAL INTERVENTION FOR THE SHUNT, THE DEVICE REPLACEMENT IS PLANNED. AT THIS TIME, THE DEVICE REMAINS IN SERVICE.FURTHER INFORMATION WAS RECEIVED FROM THE FIELD REPRESENTATIVE THAT MULTIPLE ATTEMPTS HAVE BEEN MADE BY THE PHYSICIAN'S OFFICE TO CONTACT THE PATIENT AND NO RESPONSE HAD BEEN RECEIVED. AT THIS TIME THE SYSTEM REMAINS IMPLANTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED IN THE OPERATING ROOM AND TWO DAYS LATER A NEW ICD WAS IMPLANTED. THE HOSPITAL RETAINED THE DEVICE, SO AT THIS TIME IT WILL NOT BE RETURNED TO BOSTON SCIENTIFIC. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM THE FIELD REPRESENTATIVE THAT THIS PATIENT REPORTED A PERMANENT FISTULA WAS IMPLANTED, BUT SEVERAL WEEKS OF HEALING WERE REQUIRED BEFORE IT WOULD BE USABLE. THE PLAN WAS THAT THE PATIENT WOULD BE FITTED FOR A LIFE VEST AND SCHEDULED FOR A DEVICE REPLACEMENT IN THE COMING MONTHS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE REMAINS IMPLANTED AT THIS TIME.

    Description of Event or Problem · 1

    FURTHER INFORMATION WAS RECEIVED THAT THE PATIENT DID NOT SHOW UP FOR HIS FOLLOW-UP APPOINTMENT AND THE CLINIC WAS ATTEMPTING TO GET THE APPOINTMENT RESCHEDULED. NO FURTHER INFORMATION HAS BEEN PROVIDED. BOSTON SCIENTIFIC HAS ISSUED AN ADVISORY COMMUNICATION REGARDING AN OLDER SUBSET OF COGNIS/TELIGEN DEVICES THAT IS MORE SUSCEPTIBLE TO A POSSIBLE LOW VOLTAGE CAPACITOR ANOMALY. SPECIFICALLY, THE PERFORMANCE OF A LOW VOLTAGE CAPACITOR MAY BE COMPROMISED OVER TIME, CAUSING AN INCREASED CURRENT DRAIN THAT CAN LEAD TO PREMATURE BATTERY DEPLETION. THIS PARTICULAR DEVICE WAS INCLUDED IN THE ADVISORY POPULATION.

    Description of Event or Problem · 1

    THE PATIENT HAD RECENT FOLLOW-UP AT THE CLINIC. ANOTHER EVALUATION OF DATA WAS DONE AND DEVICE REPLACEMENT CONTINUES TO BE RECOMMENDED. DATA ANALYSIS WAS PERFORMED AND IT WAS RECOMMENDED THE DEVICE BE REPLACED BY MID-JULY. NO ADVERSE PATIENT EFFECTS WERE REPORTED, AND AT THIS TIME, INFORMATION SUGGESTS THE DEVICE REMAINS IN SERVICE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS DEVICE REPORTED HEARING BEEPING. UPON INTERROGATION IT WAS OBSERVED THIS DEVICE RECORDED A CODE 1003 INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY. DATA ANALYSIS SHOWED THE BATTERY APPEARS TO BE DEPLETING MORE QUICKLY THAN EXPECTED. DEVICE REPLACEMENT WAS RECOMMENDED. AT THIS TIME, INFORMATION SUGGESTS THAT THE DEVICE REMAINS IMPLANTED. NO ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

    FURTHER INFORMATION WAS RECEIVED THAT THIS PATIENT WAS SEEN IN (B)(6) 2014 AND THE DEVICE HAD NOT YET REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). THE PHYSICIAN WAS ATTEMPTING TO REACH THE PATIENT TO SCHEDULED ANOTHER FOLLOW-UP CLINIC CHECK. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384915 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| R 0138| E102