BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 106

    MDR report key: 5890558 · Received August 19, 2016

    Report

    Report Number
    1644487-2016-01878
    Event Type
    Malfunction
    Date Received
    August 19, 2016
    Date of Event
    July 27, 2016
    Report Date
    July 27, 2016
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SERIAL #, CORRECTED DATA: (B)(4). INITIAL MDR INADVERTENTLY DID NOT LIST THE PRODUCT SERIAL # . LOT #, CORRECTED DATA: 203490. INITIAL MDR INADVERTENTLY DID NOT LIST THE PRODUCT LOT #. EXPIRATION DATE (MO/DAY/YR), CORRECTED DATA: 02/18/2017. INITIAL MDR INADVERTENTLY DID NOT LIST THE PRODUCT EXPIRATION DATE . DEVICE MANUFACTURE DATE (MO/DAY/YR), CORRECTED DATA: 05/26/2016. INITIAL MDR INADVERTENTLY DID NOT LIST THE DEVICE MANUFACTURE DATE. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAS THE GENERATOR IMPLANTED IN THE RIGHT CHEST AND ELECTRODES IMPLANTED ON LEFT VAGUS NERVE. THE PHYSICIAN INQUIRED IF THE PLACEMENT OF THE DEVICES WOULD CONTRIBUTE TO PROBLEMS WITH THE HEART RATE SENSING OF THE M106 AS THE NEUROLOGIST WAS UNABLE TO GET THE HB DETECTION TO PERFORM. THE PATIENT¿S GENERATOR WAS IMPLANTED ON THE RIGHT SINCE THE PATIENT HAS A PACEMAKER IMPLANTED ON THE LEFT. PER LABELING, THE IMPLANT LOCATION OF THE MODEL 106 PULSE GENERATOR CRITICALLY AFFECTS ITS ABILITY TO PROPERLY SENSE HEART BEATS. IMPROPER IMPLANT LOCATION AND/OR HEARTBEAT DETECTION SENSITIVITY SETTING COULD (B)(6) IMPACT R-WAVE DETECTION PERFORMANCE RESULTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON HAD TO IMPLANT THE M 106 GENERATOR ON THE RIGHT CHEST OF THE PATIENT ON (B)(6) 2016 AND THAT THE HEARTBEAT VERIFICATION WAS UNSUCCESSFUL. IT IS UNKNOWN IF A PRE-SURGICAL EVALUATION WAS PERFORMED AND IF ALL THE TROUBLESHOOTING STEPS WERE COMPLETED. ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION WERE MADE BUT NO ADDITIONAL RELEVANT INFORMATION WAS RECEIVED.

    Description of Event or Problem · 1

    PRODUCT INFORMATION WAS RECEIVED ON 08/08/2016. A REVIEW OF DEVICE HISTORY RECORDS FOR THE GENERATOR SHOWS THAT NO UNRESOLVED NON-CONFORMANCES WERE FOUND. THE R-WAVE VERIFICATION STEP WAS SUCCESSFUL PER THE DEVICE HISTORY RECORDS. THE GENERATOR IS NOT A LASER ROUTED DEVICE. ADDITIONAL RELEVANT INFORMATION HAS NOT BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542705 PULSE GEN MODEL 106 GENERATOR LYJ CYBERONICS, INC. 106 203490

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR