BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S-ICD SYSTEM

    MDR report key: 5253436 · Received November 28, 2015

    Report

    Report Number
    3009448963-2015-00657
    Event Type
    Malfunction
    Date Received
    November 28, 2015
    Date of Event
    May 22, 2012
    Report Date
    November 2, 2015
    Manufacturer
    CAMERON HEALTH
    Product Code
    LWS
    UDI-DI
    00802526521362
    PMA / PMN Number
    P11042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING AN INTERNAL LOG FILE REVIEW, IT WAS DISCOVERED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) HAD DISPLAYED A DA ERROR MESSAGE. IT WAS DETERMINED THAT A MEMORY INCONSISTENCY OCCURRED THAT WAS SELF-CORRECTED BY THE DEVICE. THE S-ICD WAS FUNCTIONING NORMALLY. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE S-ICD REMAINED IMPLANTED AND IN SERVICE. AT A LATER DATE, THIS S-ICD WAS EXPLANTED DUE TO AN UNRELATED PRODUCT PERFORMANCE ISSUE. THE INFORMATION ON THAT EVENT IS CONTAINED IN MDR# 9912058-2014-00010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783524 S-ICD SYSTEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CAMERON HEALTH 1010 00802526521362

    Patients

    Seq Age Sex Outcome Treatment
    1