BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADYM RF

    MDR report key: 8183702 · Received December 20, 2018

    Report

    Report Number
    1000165971-2018-01084
    Event Type
    Injury
    Date Received
    December 20, 2018
    Date of Event
    November 28, 2018
    Report Date
    March 25, 2019
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    MRM
    PMA / PMN Number
    P060027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRELIMINARY ANALYSIS SUGGESTS THAT THE REPORTED INTERROGATION FAILURE WAS DUE TO BATTERY DEPLETION.

    Additional Manufacturer Narrative · 0

    PLEASE REFER TO THE ATTACHED ANALYSIS REPORT. - ATTACHMENT: [20190308 - FILE-2018-03900 - ANALYSIS_AND_CLOSURE_REPORT_RESP-2019-00277.PDF].

    Description of Event or Problem · 0

    AN CRITICAL ALERT RELATED TO THE SUBJECT DEVICE WAS SENT BY THE REMOTE MONITORING SYSTEM ON (B)(6)2018. THE PATIENT CAME IN TO THE HOSPITAL AND THE PHYSICIAN WAS UNABLE TO INTERROGATE THE DEVICE, DESPITE TWO SEPARATE PROGRAMMERS BEING USED AND THE LOCATION BEING CHANGED TO EXCLUDE THE POSSIBILITY OF EXTERNAL INTERFERENCE DISRUPTING THE TELEMETRY. NO GREEN LIGHTS WERE OBSERVED ON THE PROGRAMMER HEAD.

    Description of Event or Problem · 0

    AN CRITICAL ALERT RELATED TO THE SUBJECT DEVICE WAS SENT BY THE REMOTE MONITORING SYSTEM ON (B)(6)2018. THE PATIENT CAME IN TO THE HOSPITAL AND THE PHYSICIAN WAS UNABLE TO INTERROGATE THE DEVICE, DESPITE TWO SEPARATE PROGRAMMERS BEING USED AND THE LOCATION BEING CHANGED TO EXCLUDE THE POSSIBILITY OF EXTERNAL INTERFERENCE DISRUPTING THE TELEMETRY. NO GREEN LIGHTS WERE OBSERVED ON THE PROGRAMMER HEAD.

    Description of Event or Problem · 1

    AN CRITICAL ALERT RELATED TO THE SUBJECT DEVICE WAS SENT BY THE REMOTE MONITORING SYSTEM ON (B)(6) 2018. THE PATIENT CAME IN TO THE HOSPITAL AND THE PHYSICIAN WAS UNABLE TO INTERROGATE THE DEVICE, DESPITE TWO SEPARATE PROGRAMMERS BEING USED AND THE LOCATION BEING CHANGED TO EXCLUDE THE POSSIBILITY OF EXTERNAL INTERFERENCE DISRUPTING THE TELEMETRY. NO GREEN LIGHTS WERE OBSERVED ON THE PROGRAMMER HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1023778 PARADYM RF DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER MRM SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM RF DR 9550 2499

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention