BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2860561 · Received December 6, 2012

    Report

    Report Number
    1644487-2012-03224
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 13, 2012
    Manufacturer
    CYBERONICS INC
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, IT WAS REPORTED THAT THE PATIENT HAD CALLED HIS PHYSICIAN'S OFFICE COMPLAINING OF "LEAKAGE FROM HIS DEVICE" AND INDICATED THAT HE HAS HAD THIS PROBLEM BEFORE. A BATTERY LIFE CALCULATION WAS PERFORMED WHICH SHOWED 11.01 YEARS REMAINING UNTIL NEOS=YES. THE PHYSICIAN HAD REPORTED THAT HE WOULD CALL THE MANUFACTURER WHEN THE PATIENT WAS GOING TO BE SEEN AGAIN BUT HE NEVER DID. THE PHYSICIAN'S OFFICE LATER REPORTED ON (B)(6) 2012 THAT "EVERYTHING HAD BEEN RESOLVED" AND THERE WAS NO LONGER AN ISSUE. THEY DID NOT PROVIDE ANY FURTHER INFORMATION AS TO HOW THE PROBLEM WAS RESOLVED OR WHAT THE PROBLEM WAS CONFIRMED TO BE. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 GENERATOR MUZ CYBERONICS INC 102 200943

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR