BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVEAL LINQ

    MDR report key: 5711147 · Received June 9, 2016

    Report

    Report Number
    2182208-2016-01435
    Event Type
    Injury
    Date Received
    June 9, 2016
    Date of Event
    January 1, 2015
    Report Date
    March 1, 2016
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DSI
    PMA / PMN Number
    K132649
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. THE BASELINE GENDER/AGE OF THE PATIENTS IS MALE/(B)(6). REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REFERENCED ARTICLE: SAFETY PROFILE OF A MINIATURIZED INSERTABLE CARDIAC MONITOR: RESULTS FROM TWO PROSPECTIVE TRIALS. PACE PACING AND CLINICAL ELECTROPHYSIOLOGY. 2015;38(12):1464-1469.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING IMPLANTABLE CARDIAC MONITORS (ICMS). MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. THE ARTICLE REPORTS THERE WERE PATIENTS WHO EXPERIENCED INSERTION SITE "SUPERFICIAL WOUND" INFECTIONS WHICH DID NOT REQUIRE TREATMENT, AND "MINOR" BLEEDING FROM THE INSERTIONS SITE WHICH STOPPED WITH APPLIED PRESSURE. THERE WERE ALSO PATIENT WHO EXPERIENCED INSERTION SITE PAIN; IN WHICH SOME PATIENTS HAD THE ICM REMOVED. IN ONE PATIENT, A "CLEAR FLUID EMANATED" FROM THE WOUND, WHICH THE PHYSICIAN INDICATED WAS NOT AN INFECTION AND THE ICM REMAINED IN USE. THERE WERE TWO PATIENTS WHO HAD INSERTION SITE INFECTIONS; ONE OF WHICH ALSO HAD "MILD ERYTHEMA" AND WAS RESOLVED WITH ANTIBIOTICS AND ONE PATIENT WHOSE INSERTION SITE WAS DRAINED AND THE DEVICE WAS EXPLANTED. THE ARTICLE ALSO INDICATED THAT THERE WAS ONE PATIENT WHO EXPERIENCED PAIN AT THE INSERTION SITE, WHICH PROGRESSED TO A "PERFORATION AND SPONTANEOUS DEVICE EXPLANT THROUGH THE INSERTION SITE." THE STATUS OF ALL THE ICMS IS UNKNOWN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN RE PORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367154 REVEAL LINQ DETECTOR AND ALARM, ARRHYTHMIA DSI MEDTRONIC, INC. LNQ11

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R