BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTVIEW

    MDR report key: 8239075 · Received January 11, 2019

    Report

    Report Number
    1000165971-2019-00030
    Event Type
    Malfunction
    Date Received
    January 11, 2019
    Date of Event
    February 2, 2018
    Report Date
    October 3, 2019
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    LWP
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN UPDATE WAS PROVIDED AS OF 17 MAY 2019: 93 HOME MONITORS WERE SUCCESSFULLY CONNECTED TO THE BACK-OFFICE; 5 PATIENTS WERE STILL PAIRED WITH A HOME MONITOR WITH AN ORANGE LIGHT.

    Additional Manufacturer Narrative · 0

    D4: PLEASE REFER TO THE DOCUMENT FILE-2019-00077_HM_CANADA_LISTSN_UPDATED.PDF FOR DEVICE SERIAL NUMBERS AFFECTED BY THIS EVENT. PLEASE REFER TO THE ATTACHED ANALYSIS REPORT. - ATTACHMENT: [FILE-2019-00077_HM_CANADA_LISTSN_UPDATED.PDF, 20190801 - FILE-2019-00077 - ANALYSIS_AND_CLOSURE_REPORT_RESP-2019-01065.PDF].

    Additional Manufacturer Narrative · 0

    THE LIST OF IMPACTED DEVICES HAS BEEN UPDATED, PLEASE REFER TO THE DOCUMENT FILE: (B)(4)CANADA_LISTSN_UPDATED. PDF FOR DEVICE SERIAL NUMBERS AFFECTED BY THIS EVENT. - ATTACHMENT: [FILE: (B)(4) CANADA_LISTSN_UPDATED.PDF].

    Additional Manufacturer Narrative · 0

    THE NUMBER OF UNITS IMPACTED BY THIS EVENT HAS INCREASED. PLEASE REFER TO THE DOCUMENT FILE-2019-00077_HM_CANADA_LISTSN_UPDATED.PDF FOR DEVICE SERIAL NUMBERS AFFECTED BY THIS EVENT. - ATTACHMENT: [FILE-2019-00077_HM_CANADA_LISTSN_UPDATED.PDF].

    Additional Manufacturer Narrative · 0

    AN UPDATE WAS PROVIDED AS OF 15 APRIL 2019: 66 HOME MONITORS WERE SUCCESSFULLY CONNECTED TO THE BACK-OFFICE; 11 PATIENTS WERE STILL PAIRED WITH A HOME MONITOR WITH AN ORANGE LIGHT.

    Description of Event or Problem · 0

    REPORTEDLY, AN ISSUE WAS OBSERVED TO SET UP NUMEROUS HOME MONITORS IN CANADA. AN ORANGE LIGHT INDICATOR ON THE MONITORS EVIDENCED DYSFUNCTION OF THE DEVICES. ONE OF THESE DEVICES WAS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 0

    REPORTEDLY, AN ISSUE WAS OBSERVED TO SET UP NUMEROUS HOME MONITORS IN CANADA. AN ORANGE LIGHT INDICATOR ON THE MONITORS EVIDENCED DYSFUNCTION OF THE DEVICES.ONE OF THESE DEVICES WAS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 0

    REPORTEDLY, AN ISSUE WAS OBSERVED TO SET UP NUMEROUS HOME MONITORS IN CANADA. AN ORANGE LIGHT INDICATOR ON THE MONITORS EVIDENCED DYSFUNCTION OF THE DEVICES. ONE OF THESE DEVICES WAS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 0

    REPORTEDLY, AN ISSUE WAS OBSERVED TO SET UP NUMEROUS HOME MONITORS IN CANADA. AN ORANGE LIGHT INDICATOR ON THE MONITORS EVIDENCED DYSFUNCTION OF THE DEVICES.ONE OF THESE DEVICES WAS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 0

    REPORTEDLY, AN ISSUE WAS OBSERVED TO SET UP NUMEROUS HOME MONITORS IN CANADA. AN ORANGE LIGHT INDICATOR ON THE MONITORS EVIDENCED DYSFUNCTION OF THE DEVICES.ONE OF THESE DEVICES WAS RETURNED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    PLEASE REFER TO THE DOCUMENT FILE (B)(4) FOR DEVICE SERIAL NUMBERS AFFECTED BY THIS EVENT. (B)(4).

    Description of Event or Problem · 1

    REPORTEDLY, AN ISSUE WAS OBSERVED TO SET UP NUMEROUS HOME MONITORS IN (B)(6). AN ORANGE LIGHT INDICATOR ON THE MONITORS EVIDENCED DYSFUNCTION OF THE DEVICES. ONE OF THESE DEVICES WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31484 SMARTVIEW PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS LWP SORIN GROUP ITALIA S.R.L. - CRM FACILITY SMARTVIEW PSTN

    Patients

    Seq Age Sex Outcome Treatment
    1