BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC LEAD

    MDR report key: 5595665 · Received April 21, 2016

    Report

    Report Number
    2182208-2016-01392
    Event Type
    Injury
    Date Received
    April 21, 2016
    Date of Event
    January 1, 2016
    Report Date
    April 5, 2016
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 LEAD/SERIAL NUMBERS. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. THE BASELINE WEIGHT/AGE OF THE PATIENTS IS (B)(6). 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: TWENTY-SEVEN YEARS EXPERIENCE WITH TRANSVENOUS PACEMAKER IMPLANTATION IN CHILDREN WEIGHING <(><<)>10 KG. CIRCULATION. ARRHYTHMIA AND ELECTROPHYSIOLOGY, 9(2), E003422.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING IMPLANTABLE PULSE GENERATOR (IPG) SYSTEMS. 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 LEAD INTERVENTIONS/REVISIONS DUE TO SKIN EROSIONS, DISPLACEMENTS, RE-SUTURING, INCREASED PACING THRESHOLDS, INSULATION BREAKS, INFECTIONS, ¿MALFUNCTIONS,¿ LEAD ¿STRAIGHTENING (LOSS OF ATRIAL LOOP), EXTRACTION DIFFICULTY, AND DAMAGE TO THE LEAD DURING AN ELECTIVE GENERATOR CHANGE. THE ARTICLE ALSO REPORTED THAT THERE WERE GENERATORS CHANGED OUT DUE TO POCKET INFECTIONS. THE ARTICLE ALSO INDICATED THAT ONE PATIENT DIED DUE TO THE ¿TEMPORARY PACING WIRES.¿ THE STATUS OF ALL LEADS AND IPGS IN UNKNOWN. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THROUGH FOLLOW UP WITH THE CO-AUTHOR WHO INDICATED THAT THERE WAS NO "SPECIFIC ISSUE" WITH ANY OF THIS MANUFACTURER'S PRODUCTS. THE COMPLICATIONS REFERENCED IN THE ARTICLE WERE RELATED TO "PATIENT FACTORS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251650 MEDTRONIC LEAD PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 00007 MO Death| H| L| R