BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVEAL LINQ

    MDR report key: 3990800 · Received August 8, 2014

    Report

    Report Number
    9614453-2014-01753
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 29, 2014
    Report Date
    June 26, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    DSI
    PMA / PMN Number
    K132649
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD BEEN EXPERIENCING PERSISTENT PAIN AT THE IMPLANTABLE CARDIAC MONITOR IMPLANT SITE. THE DEVICE WAS EXPLANTED AT THE PATIENT'S REQUEST. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471483 REVEAL LINQ DETECTOR AND ALARM, ARRHYTHMIA DSI IPG MFG SWITZERLAND LNQ11

    Patients

    Seq Age Sex Outcome Treatment
    1 00034 YR Hospitalization| R