BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3180795 · Received June 20, 2013

    Report

    Report Number
    1644487-2013-01864
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    January 24, 2006
    Report Date
    May 21, 2013
    Manufacturer
    CYBERONICS
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY THE MANUFACTURER, LEAD PIN NOT FULLY INSERTED PAST THE CONNECTOR BLOCK OF GENERATOR.

    Description of Event or Problem · 1

    DURING PROGRAMMING HISTORY REVIEW IT WAS DISCOVERED THAT HIGH IMPEDANCE (DC DC CODE 5) WAS OBTAINED APPROXIMATELY TWO MONTHS AFTER THE PATIENT UNDERWENT GENERATOR REPLACEMENT SURGERY. PREVIOUSLY IT WAS REPORTED THAT THE HIGH IMPEDANCE WAS FIRST OBTAINED ON (B)(6) /2006; HOWEVER, THE PROGRAMMING HISTORY CONFIRMS THAT THE HIGH IMPEDANCE WAS FIRST OBSERVED ON (B)(6) 2006. X-RAYS REVIEWED BY MANUFACTURER REVEALED THAT THE LEAD CONNECTOR PIN WAS NOT FULLY INSERTED INTO THE GENERATOR CONNECTOR BLOCK. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2006. IT WAS NOTED THAT THE LEAD WAS REINSERTED INTO THE GENERATOR HEADER AND DIAGNOSTIC TESTING WAS THEN WITHIN NORMAL LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280198 PULSE GEN MODEL 102 GENERATOR MUZ CYBERONICS 102 012830

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR