BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVEAL LINQ

    MDR report key: 4830153 · Received June 10, 2015

    Report

    Report Number
    9614453-2015-01309
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    March 2, 2015
    Report Date
    March 5, 2015
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    DSI
    PMA / PMN Number
    K132649
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS WAS PERFORMED AND NO ANOMALIES FOUND. THIS EVENT OCCURRED OUTSIDE THE US WHERE A SIMILAR MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY SIX WEEKS AFTER IMPLANT THE PATIENT WAS SEEN AND ALTHOUGH THERE SEEMED TO BE A SCAB AT THE SIGHT OF IMPLANT IT LOOKED OKAY. THE PATIENT WAS ASKED TO COME BACK IF THERE WERE ANY PROBLEMS. THE WOUND HAS NEVER HEALED PROPERLY AND THE END OF THE DEVICE (ABOUT 5MM) WAS NOW OUTSIDE OF THE BODY. THE SITE ISN¿T SORE, HOT TO TOUCH OR WEEPING, AND IT SEEMS THE SKIN HAS HEALED AROUND IT. THE IMPLANTABLE CARDIAC MONITOR WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373535 REVEAL LINQ DETECTOR AND ALARM, ARRHYTHMIA DSI IPG MFG SWITZERLAND LNQ11

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R