BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 5646197 · Received May 11, 2016

    Report

    Report Number
    1644487-2016-00990
    Event Type
    Malfunction
    Date Received
    May 11, 2016
    Date of Event
    April 8, 2016
    Report Date
    December 30, 2019
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PREVIOUSLY SUBMITTED MDR INADVERTENTLY PROVIDED THE WRONG SUSPECT DEVICE FOR THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VNS PATIENT COMPLAINED THAT HER GENERATOR IS NOT WORKING WELL, IT STIMULATES MORE THAN IT SHOULD ACCORDING TO THE DUTY CYCLE. THE FLASHCARD DATA WAS DOWNLOADED BUT HAS NOT BEEN RECEIVED TO DATE FOR REVIEW. THE REVIEW OF MANUFACTURING RECORDS CONFIRMED THAT THE GENERATOR PASSED ALL FUNCTIONAL TESTS PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    THE AVAILABLE PROGRAMMING HISTORY DATA WAS REVIEWED. THE DATA WAS OBSERVED FROM (B)(6) 2014 THROUGH (B)(6) 2016. THE DEVICE WAS LAST PROGRAMMED ON (B)(6) 2016 AT 1.5MA/20HZ/50¿SEC /7SEC/0.5MIN (30% DUTY CYCLE) AND MAGNET MODE WAS 1.75MA/60SEC/250¿SEC. ON (B)(6) 2015, THE DEVICE WAS PROGRAMMED AT 2MA/20HZ/500¿SEC/7SEC/0.3MIN (44% DUTY CYCLE) AND MAGNET MODE WAS 2.25MA/60SEC/250¿SEC, THE PATIENT GENERATOR WAS INTERROGATED PRIOR LEAVING THE CLINIC ON (B)(6) 2015 AND THE SETTINGS WERE OK. THE SYSTEM DIAGNOSTIC TEST WAS ALSO OK ON THAT DATE (2924 OHMS). ON (B)(6) 2015, THE DEVICE WAS PROGRAMMED ON 2MA/20HZ/500¿SEC/7SEC/0.5MIN (30% DUTY CYCLE). DUE TO THE PATIENT¿S SYMPTOMS THE PATIENT¿S DEVICE WAS TURNED OFF ON (B)(6) 2016 (INCLUDING A DECREASE OF PULSE WIDTH TO 250¿SEC). THE FIRST INTERROGATION OF THE PATIENT¿S DEVICE ON 04/13/2016 REVEALED THE FOLLOWING SETTINGS 0MA/20HZ//250¿SEC/7SEC/0.8MIN (20% DUTY CYCLE), THE DEVICE WAS RE-PROGRAMMED ON THE SAME DATE TO 1.5MA/20HZ//250¿SEC/7SEC/0.5MIN (30% DUTY CYCLE). FOLLOW UP INDICATED THAT THE PATIENT¿S DEVICE WAS TURNED OFF ON (B)(6) 2016 BY THE MEDICAL PROFESSIONAL DUE TO THE PATIENT¿S SYMPTOMS. THE THERAPY WAS TURNED ON AGAIN ON (B)(6) 2016. THE PATIENT IS DOING WELL NOW AND THERE HAS BEEN NO RE-OCCURRENCE OF THE SYMPTOMS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT DURING THE TIME OF THE REPORTED EVENT OF THE PATIENT FEELING STIMULATION MORE OFTEN THAN WHAT THE PATIENT WAS PROGRAMMED TO, THE CLINIC WAS ABLE TO NOTICE THIS DUE TO THE HOARSENESS THE PATIENT WAS HAVING DURING STIMULATION.

    Description of Event or Problem · 1

    PROGRAMMING HISTORY WAS REVIEWED. THE DATA WAS OBSERVED FROM (B)(6) 2015 THROUGH (B)(6) 2016. ON (B)(6) 2015, THE DEVICE WAS PROGRAMMED ON 2MA/20HZ/500 SEC/7SEC/0.5 OFF TIME (FINAL INTERROGATION PERFORMED ON THAT DATE). THE DEVICE WAS INTERROGATED ON (B)(6) 2016 AND FOUND ON THE FOLLOWING SETTINGS 0 MA/20HZ//250 SEC/7SEC/0.8 OFF TIME, THE GENERATOR WAS RE-PROGRAMMED ON 1.5 MA/20HZ/250 S/7SEC/0.5MIN. IT IS MOST LIKELY THAT THE PATIENT WAS FOLLOWED UP BY OTHER PHYSICIAN BETWEEN (B)(6) 2015 AND (B)(6) 2016. NO DIAGNOSTIC DATA IS AVAILABLE. THE REASON OF THE OBSERVED DEVICE SWITCH OFF AND PARAMETER CHANGES IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304222 PULSE GEN MODEL 103 GENERATOR LYJ LIVANOVA USA, INC. 103 3836

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR