BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2850378 · Received November 29, 2012

    Report

    Report Number
    1644487-2012-03134
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    September 10, 2012
    Report Date
    October 31, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECT MEDICAL DEVICE TYPE OF DEVICE: PATIENT IMPLANTED FOR DEPRESSION NOT EPILEPSY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VNS PATIENT WAS GOING TO HAVE THEIR GENERATOR EXPLANTED ON (B)(6) 2012. THE EXPLANT WAS DUE TO THE DEVICE BEING TURNED OFF FOR THE PAST 2-3 YEARS. THE DEVICE WAS DISABLED DUE TO A RESPIRATORY EVENT. THE PATIENT'S PHYSICIAN DID NOT THINK IT WAS AN ARREST, BUT DID NOT KNOW WHAT EXACTLY OCCURRED. THE GENERATOR AND MOST OF THE LEAD (NOT ELECTRODES) WAS EXPLANTED. FURTHER INFORMATION HAS NOT BEEN RECEIVED AT THIS TIME.

    Description of Event or Problem · 1

    AT THIS TIME THE PATIENT'S EXPLANTED PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 PULSE GEN MODEL 102 MUZ CYBERONICS, INC. 102 014585

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention