BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ICD SYSTEM

    MDR report key: 2932166 · Received January 25, 2013

    Report

    Report Number
    3009448963-2013-00005
    Event Type
    Injury
    Date Received
    January 25, 2013
    Date of Event
    December 12, 2012
    Report Date
    October 8, 2015
    Manufacturer
    CAMERON HEALTH
    Product Code
    LWS
    PMA / PMN Number
    P11042
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY CAMERON HEALTH'S QUALITY LABORATORY. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    CAMERON HEALTH RECEIVED INFORMATION THAT APPROXIMATELY TWO YEARS, THREE MONTHS AFTER IMPLANT THE PATIENT PRESENTED TO THE HOSPITAL BECAUSE BEEPING TONES WERE EMITTING FROM THE PULSE GENERATOR ("DEVICE"). IT WAS REPORTED THAT UPON INTERROGATION OF THE DEVICE, A RED SCREEN APPEARED (BATTERY DEPLETION ERROR) WITH INSTRUCTIONS TO CONTACT CAMERON HEALTH. AT THAT TIME THE BATTERY LEVEL WAS REPORTED AS 50%. IT WAS FURTHER REPORTED THAT THE PATIENT WAS SENT HOME AND INSTRUCTED TO RETURN TO THEIR CLINIC TO CAPTURE LOG DATA FOR ANALYSIS. THE PATIENT RETURNED TO THEIR CLINIC THREE WEEKS LATER. WHEN THE DEVICE WAS INTERROGATED, THE BATTERY LEVEL OF 5% WAS DISCOVERED. CAMERON HEALTH CONFIRMED THE BATTERY LEVEL VIA LOG FILE REVIEW AND THE DEVICE WAS EXPLANTED AND REPLACED WITH ANOTHER PULSE GENERATOR ONE DAY LATER. THE ELECTRODE REMAINED IMPLANTED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED DURING THE REPLACEMENT PROCEDURE. THE EXPLANTED DEVICE WAS RETURNED TO CAMERON HEALTH FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36099 S-ICD SYSTEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CAMERON HEALTH 1010

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Male Life Threatening| H| R 3010.