BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 7092537 · Received December 7, 2017

    Report

    Report Number
    2182208-2017-02023
    Event Type
    Injury
    Date Received
    December 7, 2017
    Date of Event
    November 27, 2016
    Report Date
    February 8, 2018
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. 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 DEVICE SERIAL NUMBERS. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. POSSIBLE MODELS INCLUDE THE CONSULTA ICD. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE:A REVIEW OF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR FAILURES DURING RADIATION THERAPY IN THREE SYDNEY HOSPITALS. JOURNAL OF MEDICAL IMAGING AND RADIATION ONCOLOGY. 2017; 61(4):517-521.

    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 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FAILURES DURING RADIATION THERAPY. MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. THE ARTICLE REPORTS THAT ONE PATIENT EXPERIENCED MULTIPLE POWER ON RESET (POR) DURING THE COURSE OF RADIATION TREATMENT. SIX SINGLE BYTE MEMORY CORRUPTIONS, WHERE SMALL AMOUNTS OF DATA ARE EITHER CORRUPTED OR LOST AS A RESULT OF RADIATION, ELECTROMAGNETIC INTERFERENCE (EMI) OR PHYSICAL DAMAGE WERE ALSO IDENTIFIED. THE ICD WAS REPROGRAMMED AND REMAINED IN USE. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED FROM THE AUTHOR INDICATED THERE ARE NO ADDITIONAL COMPLAINTS AND NO INFORMATION ON PRODUCT SERIAL NUMBERS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872187 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-ICD

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention