BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 7022787 · Received November 10, 2017

    Report

    Report Number
    1644487-2017-04760
    Event Type
    Injury
    Date Received
    November 10, 2017
    Date of Event
    January 1, 2016
    Report Date
    November 10, 2017
    Manufacturer
    CYBERONICS - HOUSTON
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SALLOUM, NAJI C., ET AL. ¿SUSTAINED REMISSION IN PATIENTS WITH TREATMENT-RESISTANT DEPRESSION RECEIVING VAGAL NERVE STIMULATION: A CASE SERIES.¿ BRAIN STIMULATION, VOL. 10, NO. 5, 2017, PP. 997¿1000., DOI:10.1016/J.BRS.2017.06.001.

    Description of Event or Problem · 1

    AN ARTICLE WAS REVIEWED WHICH STUDIED SUSTAINED REMISSION IN VNS PATIENTS WITH TREATMENT RESISTANT DEPRESSION. THE ARTICLE DESCRIBED A PATIENT WHO WAS IN REMISSION AFTER 6 MONTHS OF IMPLANT BUT RELAPSED 3 YEARS LATER DUE TO VNS BATTERY EXPIRATION. THE BATTERY WAS REPLACED AT MONTH 44 AND THE PATIENT RETURNED TO REMISSION. FURTHER FOLLOW-UP WITH THE STUDY¿S AUTHOR FOUND THAT THE BATTERY FAILURE WAS EXPECTED BATTERY DEPLETION AND IT APPEARED THAT THE PATIENT¿S REPLACEMENT OCCURRED SOMETIME IN 2016. HOWEVER THE EXACT DATE OF REPLACEMENT HAS NOT BEEN OBTAINED TO DATE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE. THE ARTICLE ALSO REFERENCES A PATIENT EXPERIENCE FROM A PREVIOUS STUDIED ENTITLED "VAGUS NERVE STIMULATION FOR DEPRESSION: A CASE OF A BROKEN LEAD, DEPRESSION RELAPSE, REVISION SURGERY, AND RESTORATION OF PATIENT RESPONSE." THIS EVENT WAS PREVIOUSLY CAPTURED IN MFG. REPORT #1644487-2009-00203.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800572 PULSE GEN MODEL 103 GENERATOR MUZ CYBERONICS - HOUSTON 103 3318

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR