BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 4576598 · Received March 6, 2015

    Report

    Report Number
    1644487-2015-04052
    Event Type
    Malfunction
    Date Received
    March 6, 2015
    Date of Event
    February 4, 2015
    Report Date
    February 4, 2015
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY THE MANUFACTURER DID NOT IDENTIFY ANY DISCONTINUITIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEVICE DIAGNOSTICS RESULTED IN HIGH IMPEDANCE (>10,000 OHMS). IT WAS REPORTED THAT REVISION SURGERY WAS PLANNED. X-RAYS WERE RECEIVED FOR REVIEW. REVIEW OF X-RAYS WAS UNABLE TO DETERMINE WHETHER OR NOT THE LEAD PIN WAS FULLY INSERTED INTO THE GENERATOR HEADER. THERE ARE NO GROSS DISCONTINUITIES WITH THE LEAD; HOWEVER, THE PRESENCE OF A MICRO-FRACTURE CANNOT BE RULED OUT. THE PATIENT UNDERWENT SURGERY AT WHICH TIME THE LEAD PIN WAS REINSERTED INTO THE GENERATOR HEADER. IT WAS REPORTED THAT REINSERTING THE LEAD PIN INTO THE GENERATOR HEADER RESOLVED THE HIGH IMPEDANCE. IT WAS REPORTED THAT THE DIAGNOSTICS DURING INITIAL IMPLANT WERE WITHIN NORMAL LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157514 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS INC 103 3767

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR