BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 5557560 · Received April 7, 2016

    Report

    Report Number
    2182208-2016-01188
    Event Type
    Injury
    Date Received
    April 7, 2016
    Date of Event
    December 1, 2015
    Report Date
    January 25, 2016
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980016
    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. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. 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 BASELINE GENDER/AGE OF THE PATIENTS REPRESENTED IN THE ARTICLE IS MALE/APPROXIMATELY (B)(6) 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: LEAD INTEGRITY ALERT IS USEFUL FOR ASSESSMENT OF PERFORMANCE OF BIOTRONIK LINOX LEADS. JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY. 2015;26(12):1340-1345. (B)(4).

    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 WHICH CONTAINED INFORMATION REGARDING CARDIAC IMPLANTABLE ELECTRONIC DEVICES AND A LEAD INTEGRITY ALERT ALGORITHM. MULTIPLE PATIENTS AND MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE/MANUFACTURER SERIAL NUMBERS. THE ARTICLE INDICATED THAT THERE WERE DEVICES REMOVED DUE TO INFECTION, ¿FALSE POSITIVES ALERTS,¿ AND ¿NOISE¿ SEEN DURING SURGERY. THE STATUS OF THE DEVICE 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
    214653 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-ICD

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Required Intervention