BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 3781350 · Received April 30, 2014

    Report

    Report Number
    1644487-2014-01134
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 3, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS AND AVAILABLE PROGRAMMING AND DIAGNOSTIC HISTORY WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THAT THE LEAD PASSED ALL FUNCTIONAL TESTS PRIOR TO DISTRIBUTION. DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    NEW INFORMATION CORRECTS THE SUSPECT DEVICE.

    Additional Manufacturer Narrative · 1

    BRAND NAME, CORRECTED DATA: PREVIOUSLY SUBMITTED MDR INDICATED THAT THE SUSPECT MEDICAL DEVICE WAS THE GENERATOR; HOWEVER, THIS IS ACTUALLY THE LEAD. TYPE OF DEVICE, CORRECTED DATA: PREVIOUSLY SUBMITTED MDR INDICATED THAT THE SUSPECT MEDICAL DEVICE WAS THE GENERATOR; HOWEVER, THIS IS ACTUALLY THE LEAD. MODEL #, SERIAL #, LOT #, EXPIRATION DATE, CORRECTED DATA: PREVIOUSLY SUBMITTED MDR INDICATED THAT THE SUSPECT MEDICAL DEVICE WAS THE GENERATOR; HOWEVER, THIS IS ACTUALLY THE LEAD. IMPLANT DATE, CORRECTED DATA: PREVIOUSLY SUBMITTED MDR INDICATED THAT THE SUSPECT MEDICAL DEVICE WAS THE GENERATOR; HOWEVER, THIS IS ACTUALLY THE LEAD. UPDATED IMPLANT DATE TO LEAD IMPLANT DATE. DEVICE MANUFACTURE DATE, CORRECTED DATA: PREVIOUSLY SUBMITTED MDR INDICATED THAT THE SUSPECT MEDICAL DEVICE WAS THE GENERATOR; HOWEVER, THIS IS ACTUALLY THE LEAD.

    Additional Manufacturer Narrative · 1

    DATE RECEIVED BY MANUFACTURER; CORRECTED DATA: THE PREVIOUSLY SUBMITTED MDR INADVERTENTLY DID NOT PROVIDE THE DATE FOR THIS FIELD WHICH IS 12/17/2014. THIS REPORT IS BEING SUBMITTED TO CORRECT THIS DATA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT¿S DEVICE SHOWED HIGH LEAD IMPEDANCE (LEAD IMPEDANCE >= 10,000 OHMS) AND AN IFI CONDITION DURING AN OFFICE VISIT ON (B)(6) 2014. THE PATIENT¿S DEVICE WAS NOT PROGRAMMED OFF AS THE PATIENT WAS DOING WELL WITH SEIZURE CONTROL AND DID NOT HAVE ANY ADVERSE EVENTS. THE PATIENT'S DEVICE SETTINGS WERE ADJUSTED DURING THE OFFICE VISIT. NO PATIENT MANIPULATION OR TRAUMA WAS REPORTED TO HAVE CAUSED OR CONTRIBUTED TO THE HIGH IMPEDANCE. X-RAYS WERE NOT TAKEN AND THE PATIENT WAS REFERRED FOR SURGERY. NO KNOWN INTERVENTIONS HAVE OCCURRED TO DATE. REVIEW OF THE AVAILABLE PROGRAMMING AND DIAGNOSTIC HISTORY SHOWED NORMAL DIAGNOSTIC RESULTS THROUGH (B)(6) 2013.

    Description of Event or Problem · 1

    AN IMPLANT CARD WAS RECEIVED INDICATING THAT THE PATIENT UNDERWENT GENERATOR REPLACEMENT. THE LEAD IMPEDANCE WITH THE NEW GENERATOR AND EXISTING LEAD WAS NOT MARKED. IT IS BELIEVED THAT THE HIGH IMPEDANCE RESOLVED WITH GENERATOR REPLACEMENT AND THAT THE HIGH IMPEDANCE WAS A RESULTED OF GENERATOR/LEAD CONNECTION ISSUE. THE GENERATOR HAS NOT BEEN RECEIVED FOR ANALYSIS TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259054 BIPOL LEAD MODEL 300 LEAD LYJ CYBERONICS, INC. 300-20 36361C

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR