BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2050076 · Received March 31, 2011

    Report

    Report Number
    1644487-2011-00690
    Event Type
    Malfunction
    Date Received
    March 31, 2011
    Date of Event
    February 11, 2011
    Report Date
    August 1, 2019
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSIONS: DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT, CORRECTED DATA: PREVIOUSLY SUBMITTED MDR INDICATED AN INCORRECT EVENT DATE. REVIEW OF PROGRAMMING HISTORY SHOWS THAT THE HIGH IMPEDANCE WAS FIRST NOTED ON (B)(6) 2011.

    Additional Manufacturer Narrative · 1

    PREVIOUSLY SUBMITTED MDR INDICATED AN INCORRECT EVENT DATE. REVIEW OF PROGRAMMING HISTORY SHOWS THAT THE HIGH IMPEDANCE WAS FIRST NOTED ON (B)(6) 2011.

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURE DATE, CORRECTED DATA: INITIAL REPORT (MEDWATCH) INADVERTENTLY LISTED 03/2006 INSTEAD OF 03/29/2006.

    Description of Event or Problem · 1

    REVIEW OF PROGRAMMING HISTORY SHOWS THAT HIGH IMPEDANCE WAS FIRST OBSERVED ON (B)(6) 2011.

    Description of Event or Problem · 1

    REVIEW OF PROGRAMMING HISTORY SHOWS THAT HIGH IMPEDANCE WAS FIRST OBSERVED ON (B)(6) 2011.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THIS PATIENT'S DEVICE HAS BEEN DISABLED. NO SURGICAL INTERVENTION HAS BEEN PLANNED THAT WE ARE AWARE OF AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED BY THE COMPANY REPRESENTATIVE THAT THROUGH REVIEW OF THE PHYSICIAN'S TABLET AND DISCUSSION WITH THE PATIENT THAT IT WAS REVEALED THE PATIENT UNDERWENT A FULL VNS REPLACEMENT SURGERY APPROXIMATELY TWO MONTHS FOLLOWING THE REPORTED EVENT. DUE TO THE LENGTH OF TIME SINCE THE REPLACEMENT, PRODUCT RETURN IS NOT EXPECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD HIGH IMPEDANCE ON DIAGNOSTICS AND A SUSPECTED LEAD FRACTURE. X-RAYS WERE TAKEN, BUT HAVE NOT BEEN SENT TO THE MFR FOR REVIEW. PER PHYSICIAN, NO ANOMALIES WERE SEEN ON THE X-RAYS. THE PT IS REPORTEDLY NOT FEELING STIMULATION ANYMORE EITHER. REVISION SURGERY IS LIKELY, BUT HAS NOT OCCURRED TO DATE. ATTEMPTS FOR FURTHER INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 MUZ CYBERONICS, INC. 302-20 1598

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR