BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC LEAD

    MDR report key: 7418160 · Received April 10, 2018

    Report

    Report Number
    2182208-2018-00585
    Event Type
    Injury
    Date Received
    April 10, 2018
    Date of Event
    November 25, 2017
    Report Date
    April 10, 2018
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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 AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. THE GENDER OF THE BASELINE CHARACTERISTICS IS MALE AND THE BASELINE AGE IS 60 YEARS OLD. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. 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. REFERENCED ARTICLE: ¿LONG-TERM INCIDENCE OF INAPPROPRIATE SHOCKS IN PATIENTS WITH IMPLANTABLE CARDIOVERTER DEFIBRILLATORS IN CLINICAL PRACTICE¿AN UNDERESTIMATED COMPLICATION?¿ J INTERV CARD ELECTROPHYSIOL (2017) 50:219¿226. HTTPS://DOI.ORG/10.1007/S10840-017-0297-8. 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 CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEMS. MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE/LEAD SERIAL NUMBERS. THERE WERE PATIENTS WHO EXPERIENCED INAPPROPRIATE SHOCKS. THE ARTICLE ALSO REPORTED THERE WERE DEVICES WITH ¿MIS-DIAGNOSED¿ DETECTIONS, OVERSENSING/T-WAVE OVERSENSING (TWOS), AND OVERSENSING DUE TO LEAD ¿DEFECTS.¿ INFECTION WAS ALSO NOTED FOR THE SYSTEMS AS A REASON FOR EXPLANTATION. THE STATUS OF THE DEVICES AND LEADS IS UNKNOWN; HOWEVER, THERE WERE DEVICES THAT WERE EXPLANTED FOR THE FOLLOWING REASONS: SYSTEM UPGRADES, AND BATTERY DEPLETION. 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
    260040 MEDTRONIC LEAD PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| L