BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 105

    MDR report key: 3854518 · Received June 6, 2014

    Report

    Report Number
    1644487-2014-01435
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 9, 2014
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS OF THE LEAD CONFIRMED ALL QUALITY TESTS WERE PASSED PRIOR TO DISTRIBUTION. DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    BRAND NAME, CORRECTED DATA: PREVIOUSLY SUBMITTED MDR INDICATED THAT THE SUSPECT MEDICAL DEVICE WAS THE LEAD; HOWEVER, THIS IS ACTUALLY THE GENERATOR. TYPE OF DEVICE, CORRECTED DATA: PREVIOUSLY SUBMITTED MDR INDICATED THAT THE SUSPECT MEDICAL DEVICE WAS THE LEAD; HOWEVER, THIS IS ACTUALLY THE GENERATOR. MODEL #, SERIAL #, LOT #, EXPIRATION DATE, CORRECTED DATA: PREVIOUSLY SUBMITTED MDR INDICATED THAT THE SUSPECT MEDICAL DEVICE WAS THE LEAD; HOWEVER, THIS IS ACTUALLY THE GENERATOR. OPERATOR OF DEVICE, CORRECTED DATA: PREVIOUSLY SUBMITTED MDR INDICATED THAT THE PATIENT WAS THE USER; HOWEVER, THIS SHOULD BE THE MEDICAL PROFESSIONAL. IF IMPLANTED, GIVE DATE (MO/DAY/YR), CORRECTED DATA: PREVIOUSLY SUBMITTED MDR PROVIDED THE IMPLANT DATE FOR THE LEAD; HOWEVER, THIS SHOULD BE FOR THE GENERATOR. DEVICE MANUFACTURE DATE, CORRECTED DATA: PREVIOUSLY SUBMITTED MDR INDICATED THAT THE SUSPECT MEDICAL DEVICE WAS THE LEAD; HOWEVER, THIS IS ACTUALLY THE GENERATOR.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE LEAD PIN WAS REINSERTED INTO THE GENERATOR DURING SURGERY AND THERE HAS BEEN NO RECURRENCE OF HIGH IMPEDANCE SINCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEVICE DIAGNOSTICS RESULTED IN HIGH AND LOW IMPEDANCE (5534 OHMS, 4298 OHMS). A SECOND DIAGNOSTIC WAS PERFORMED WHICH AGAIN RESULTED IN HIGH IMPEDANCE (5587 OHMS). IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE GENERATOR REPLACEMENT THE DAY PRIOR AND THAT DEVICE DIAGNOSTICS AT THE COMPLETION OF SURGERY WERE WITHIN NORMAL LIMITS. IT WAS LATER REPORTED THAT THE PATIENT WAS SENT FOR SURGERY. PRE-OPERATIVE DIAGNOSTICS RESULTED IN OK IMPEDANCE (1985 OHMS, 2020 OHMS, 2268 OHMS). IT WAS REPORTED THAT THE SURGEON PLANS TO GO FORWARD WITH THE SURGERY TO CHECK LEAD PIN/GENERATOR CONNECTION. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332273 PULSE GEN MODEL 105 GENERATOR LYJ CYBERONICS INC 105 3819

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR