BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENRHYTHM

    MDR report key: 7416123 · Received April 10, 2018

    Report

    Report Number
    2182208-2018-00505
    Event Type
    Injury
    Date Received
    April 10, 2018
    Date of Event
    January 1, 2017
    Report Date
    May 10, 2018
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. 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: ¿PACEMAKER MALFUNCTION ASSOCIATED WITH PROTON BEAM THERAPY: A REPORT OF TWO CASES AND REVIEW OF LITERATURE-DOES FIELD-TO-GENERATOR DISTANCE MATTER?¿ OXFORD MEDICAL CASE REPORTS. 2017; 2016(8):190-194. DOI: 10.1093/OMCR/OMW049. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 THIS PATIENT¿S IMPLANTABLE PULSE GENERATOR (IPG). THE ARTICLE REPORTED THAT THE PATIENT EXPERIENCED A POWER-ON-RESET WHILE BEING TREATED WITH THE PROTON BEAM THERAPY FOR LUNG CANCER. THE CHANGE IN DEVICE PARAMETERS WAS FOUND THROUGH PROGRAMMER ANALYSIS OF THE DEVICE ON THE LAST DAY OF TREATMENT. OF NOTE, ¿PHANTOM TESTING¿ OF THE SAME DEVICE WAS DONE PRIOR TO THE PATIENT TREATMENT AND NO DEVICE ABNORMALITIES WERE FOUND. THE STATUS/LOCATION OF THE DEVICE IS UNKNOWN. THE PATIENT REMAINED ¿ASYMPTOMATIC¿ AFTER THE DEVICE RESET. 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

    ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW UP WITH THE COMPANY REPRESENTATIVE WHO CONFIRMED THAT THE RESET HAD OCCURRED DURING THE PROTON BEAM THERAPY. NO FURTHER INFORMATION WILL BE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257288 ENRHYTHM PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC, INC. MDT-IPG

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| L| R