BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S-ICD SYSTEM

    MDR report key: 5241931 · Received November 22, 2015

    Report

    Report Number
    3009448963-2015-00638
    Event Type
    Malfunction
    Date Received
    November 22, 2015
    Date of Event
    November 9, 2015
    Report Date
    February 29, 2016
    Manufacturer
    CAMERON HEALTH
    Product Code
    LWS
    UDI-DI
    00802526573705
    PMA / PMN Number
    P11042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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); THE S-ICD SYSTEM REMAINS IMPLANTED AND IN SERVICE. 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); AN INVESTIGATION INTO THIS ISSUE IS CURRENTLY ONGOING. ONCE ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS OBTAINED FROM THE FIELD REPRESENTATIVE THAT NO FURTHER DEFIBRILLATION THRESHOLD (DFT) TESTING OR CHEST X-RAYS HAVE BEEN PERFORMED. OUR RECORDS INDICATE THAT THE SYSTEM REMAINS IMPLANTED AND IN SERVICE.

    Description of Event or Problem · 1

    DATA WAS THEN SUBMITTED TO BOSTON SCIENTIFIC ENGINEERING FOR FURTHER REVIEW. THE DATA SHOWED THERE WERE THREE INDUCTION ATTEMPTS LASTING 2-4 SECONDS FOLLOWED BY A SESSION END. A NEW SESSION WAS THEN INITIATED LASTING 2-8 SECONDS. ALL INDUCTION ATTEMPTS SHOW SUCCESSFUL CHARGES TO THE TARGET VOLTAGE WHICH IS NORMAL PRODUCT FUNCTION. THERE WAS NO EVIDENCE OF A TELEMETRY ISSUE DURING THE PROCEDURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) AND ELECTRODE, THE PATIENT WAS NOT ABLE TO BE INDUCED INTO A VENTRICULAR FIBRILLATION (VF) TO TEST THE SYSTEM. THE S-ICD DELIVERED THE BURSTS, BUT IT DID NOT CAUSE THE HEART TO GO INTO AN ARRHYTHMIA. DURING THE THIRD ATTEMPT TO INDUCE, THE S-ICD DID NOT DELIVER THE BURSTS AS THE PROGRAMMER FROZE. THE FIELD REPRESENTATIVE EXITED OUT OF THE SESSION AND RE-INTERROGATED THE S-ICD. SEVERAL ADDITIONAL ATTEMPTS TO INDUCE VF WERE PERFORMED BUT UNSUCCESSFUL. IN ORDER TO TEST THE SYSTEM, TWO 10 JOULE SYNCHRONIZED SHOCKS WERE DELIVERED. THE SHOCK IMPEDANCE FOR EACH DELIVERED SHOCK WAS 24 OHMS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. FURTHER TESTING, INCLUDING CHEST X-RAYS, WILL BE PERFORMED TO ASSESS THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772329 S-ICD SYSTEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CAMERON HEALTH 1010 00802526573705

    Patients

    Seq Age Sex Outcome Treatment
    1