BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DETECTOR AND ALARM, ARRHYTHMIA

    MDR report key: 7418049 · Received April 10, 2018

    Report

    Report Number
    2182208-2018-00575
    Event Type
    Injury
    Date Received
    April 10, 2018
    Date of Event
    November 2, 2017
    Report Date
    April 10, 2018
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DSI
    PMA / PMN Number
    P990001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE/SERIAL NUMBERS. THE GENDER OF THE BASELINE CHARACTERISTICS IS MALE AND THE BASELINE AGE IS 64 YEARS OLD. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: IMPLANTABLE LOOP RECORDERS IN THE REAL WORLD: A STUDY OF TWO CANADIAN CENTERS. JOURNAL OF INTERVENTIONAL CARDIAC ELECTROPHYSIOLOGY. 2017; 50(2):179-185. 10.1007/S10840-017-0294-Y. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING IMPLANTABLE CARDIAC MONITORS (ICMS). MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. THE ARTICLE REPORTS THAT PATIENTS EXPERIENCED INFECTION OF THE IMPLANT SITE, PAIN AT THE IMPLANT SITE REQUIRING DEVICE REMOVAL OR DEVICE REVISION, HYPERTROPHIC SCARRING OF THE IMPLANT SITE, AND DEVICE UNDERSENSING. THE STATUS OF THE DEVICES IS UNKNOWN. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260017 DETECTOR AND ALARM, ARRHYTHMIA DSI MEDTRONIC, INC. MDT-ILR

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention