BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVEAL LINQ

    MDR report key: 3992405 · Received August 8, 2014

    Report

    Report Number
    9614453-2014-01982
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 26, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    DSI
    PMA / PMN Number
    K132649
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THE RETURNED DEVICE INDICATED SHORTING/LOW IMPEDANCE IN AN INTEGRATED CIRCUIT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE LOOP RECORDER WAS UNABLE TO ESTABLISH TELEMETRY WITH THE REMOTE MONITOR, PATIENT ASSIST OR PROGRAMMER. THE PATIENT FURTHER REPORTED THAT SEVERAL WEEKS POST IMPLANT THE IMPLANT SITE WAS VERY TENDER AND HAD NOT HEALED. THE ILR WAS EXPLANTED AND WAS NOT REPLACED PER PATIENT REQUEST. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472505 REVEAL LINQ DETECTOR AND ALARM, ARRHYTHMIA DSI IPG MFG SWITZERLAND LNQ11

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR