BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 8103

    MDR report key: 15893856 · Received December 1, 2022

    Report

    Report Number
    1644487-2022-01533
    Event Type
    Malfunction
    Date Received
    December 1, 2022
    Date of Event
    February 14, 2022
    Report Date
    December 1, 2022
    Manufacturer
    CYBERONICS - HOUSTON
    Product Code
    MUZ
    UDI-DI
    05425025750504
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    LIVANOVA USA, INC. SUBMITS THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION, BASED ON INFORMATION THAT LIVANOVA HAS OBTAINED, BUT MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION, OR A CONCLUSION BY FDA OR ANYONE ELSE, THAT THE DEVICE, LIVANOVA, OR LIVANOVA'S EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS¿ OR "MALFUNCTIONS¿. THESE WORDS ARE INCORPORATED INTO THE FDA 3500A MEDWATCH FORM BY THE FDA, AND LIVANOVA OBJECTS TO THEIR USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT HAS A DEVICE DEFICIENCY NOTED AS THE MAGNET NOT INHIBITING STIMULATION. THE DEVICE WAS EXPLANTED AND RETURNED FOR ANALYSIS. PRODUCT ANALYSIS WAS APPROVED. THE PULSE GENERATOR WAS UNABLE TO BE INTERROGATED AS RECEIVED, SO IT WAS CONVERTED FROM A M8103 TO A M103, AND INTERROGATION WAS SUCCESSFUL. THIS CONVERSATION ENABLED MAGNET CURRENT FUNCTIONS THAT ARE UNAVAILABLE WITH M8103 DEVICES. HOWEVER, WHEN A MAGNET WAS APPLIED TO THE GENERATOR AT DISTANCES OF 1.25 AND 0 INCHES, MAGNET CURRENT WOULD NOT ACTIVATE. THE REED SWITCH WAS FOUND TO BE STUCK OPEN. THE VOLTAGE MEASURED AT THE REED SWITCH BEFORE CLOSURE WAS APPROXIMATELY 1.55 VOLTS. WHEN THE MAGNET WAS APPLIED TO CLOSE THE REED SWITCH, THE VOLTAGE WAS APPROXIMATELY 0.23 VOLTS. AFTER MULTIPLE REED SWITCH CLOSURES, THE REED SWITCH BECAME FUNCTIONAL. THE FAILURE MECHANISM FOR THE AS-RECEIVED CONDITION WITH THE NON-CLOSURE OF THE REED SWITCH WAS NOT DETERMINED. DEVICE HISTORY RECORDS WERE REVIEWED FOR THE GENERATOR WHICH PASSED ALL SPECIFICATIONS AND HAD NO NON-CONFORMANCES PRIOR TO DISTRIBUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2662949 PULSE GEN MODEL 8103 GENERATOR MUZ CYBERONICS - HOUSTON 8103 205219 05425025750504

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female