BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 6239567 · Received January 10, 2017

    Report

    Report Number
    2182208-2017-00009
    Event Type
    Injury
    Date Received
    January 10, 2017
    Date of Event
    January 1, 2015
    Report Date
    December 15, 2016
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. MULTIPLE PATIENTS 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 BASELINE AGE/WEIGHT OF THE PATIENTS IS 12 YEARS OF AGE/48 KG. 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. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. REFERENCED ARTICLE: ¿CATHETER ABLATION OF PEDIATRIC AV NODAL REENTRANT TACHYCARDIA: RESULTS IN SMALL CHILDREN.¿ CLIN RES CARDIOL (2015) 104:990¿997. DOI 10.1007/S00392-015-0868-6. 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 RECEIVED WHICH CONTAINED INFORMATION REGARDING ABLATION CATHETERS. MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT SERIAL NUMBERS. THE ARTICLE INDICATED THAT THERE WERE PATIENTS WHO EXPERIENCED PERICARDIAL TAMPONADE, WHICH REQUIRED DRAINAGE TREATMENT TO RESOLVE. THERE WAS ALSO A REPORT OF ¿STIFFNESS¿ OF THE ABLATION CATHETER, WHICH THE AUTHOR INDICATED MAY HAVE CONTRIBUTED TO THE ISSUES. THE STATUS/LOCATION OF THE CATHETER 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
    20446 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization| L| R MAPPING NAVIGATION SYSTEM