BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVEAL LINQ

    MDR report key: 6932369 · Received October 9, 2017

    Report

    Report Number
    2182208-2017-01780
    Event Type
    Injury
    Date Received
    October 9, 2017
    Date of Event
    March 28, 2017
    Report Date
    July 27, 2017
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DSI
    PMA / PMN Number
    K132649
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT SERIAL NUMBERS. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. THE GENDER OF THE BASELINE CHARACTERISTICS IS MALE AND THE BASELINE AGE IS 74 YEARS OLD. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. 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: ¿COMPLICATIONS AFTER IMPLANTATION OF A NEW-GENERATION INSERTABLE CARDIAC MONITOR: RESULTS FROM THE LOOP STUDY.¿ INTERNATIONAL JOURNAL OF CARDIOLOGY. 2017; 241:229-234. HTTP://DX.DOI.ORG/10.1016/J.IJCARD.2017.03.144. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. 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 INSERTABLE CARDIAC MONITORS (ICMS). MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE SERIAL NUMBERS WITH THE AVAILABLE INFORMATION PROVIDED. THE AUTHOR REPORTED THAT THERE WERE SEVEN (7) PATIENTS WHO HAD PROCEDURAL DIZZINESS. THERE WERE ALSO FIFTEEN (15) PATIENTS WHO SHOWED INFECTIONS, POST-IMPLANT PAIN, ¿MINOR¿ BLEEDING, AND HEMATOMAS; ALL OF WHICH WERE TREATED ¿CONSERVATIVELY,¿ OR BY SUTURING THE WOUND. FOR THESE PATIENTS, THE DEVICE WAS NOT EXPLANTED. THERE WERE NINE (9) PATIENTS WHOSE DEVICE WAS EXPLANTED FOR THE FOLLOWING REASONS: INFECTION, POST-IMPLANT PAIN, AND POCKET EROSION. EIGHT (8) OF THESE PATIENTS HAD A NEW DEVICE IMPLANTED. THE STATUS/LOCATION OF THE ICM IS UNKNOWN. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710410 REVEAL LINQ DETECTOR AND ALARM, ARRHYTHMIA DSI MEDTRONIC, INC. LNQ11

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R