BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL UNKNOWN

    MDR report key: 6048638 · Received October 21, 2016

    Report

    Report Number
    1644487-2016-02432
    Event Type
    Malfunction
    Date Received
    October 21, 2016
    Report Date
    September 25, 2016
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION WAS INADVERTENTLY LEFT OFF OF THE INITIAL MFR. REPORT.

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT; CORRECTED DATA: THIS INFORMATION WAS INADVERTENTLY LEFT OFF OF THE INITIAL MFR. REPORT. SEX; CORRECTED DATA: THIS INFORMATION WAS INADVERTENTLY LEFT OFF OF THE INITIAL MFR. REPORT. ADVERSE EVENT AND/OR PRODUCT PROBLEM; CORRECTED DATA: THIS INFORMATION WAS INADVERTENTLY LEFT OFF OF THE INITIAL MFR. REPORT. OUTCOMES ATTRIBUTED TO ADVERSE EVENT; CORRECTED DATA: THIS INFORMATION WAS INADVERTENTLY LEFT OFF OF THE INITIAL MFR. REPORT. DESCRIBE EVENT OR PROBLEM; CORRECTED DATA: THIS INFORMATION WAS INADVERTENTLY LEFT OFF OF THE INITIAL MFR. REPORT. RELEVANT TESTS/LABORATORY DATA; CORRECTED DATA: THIS INFORMATION WAS INADVERTENTLY LEFT OFF OF THE INITIAL MFR. REPORT.

    Description of Event or Problem · 1

    AN ARTICLE WAS FOUND WHICH CONTAINED INFORMATION REGARDING THE IN SITU REPAIR OF THE VNS LEAD PRODUCT FOR 6 PATIENTS. IT WAS NOTED THAT 5 OF THE 6 PATIENTS HAD LOW IMPEDANCE VALUES PRE-OPERATIVELY, AND THE 6TH PATIENT HAD NORMAL IMPEDANCE, BUT WAS FOUND DURING THE COURSE OF AN ELECTIVE GENERATOR REPLACEMENT TO HAVE FRACTURED ELECTRODE INSULATION. IT WAS NOTED THAT WHERE THE LEAD INSULATION WAS NOTED TO BE COMPROMISED, IT WAS IRRIGATED WITH ANTIBIOTIC-CONTAINING SOLUTION AND DRIED WITH A GAUZE SPONGE. AN APPROPRIATE LENGTH OF SILASTIC TUBING THAT WAS SUFFICIENT TO COVER THE DAMAGED OUTER SHEATH WITH AN ADDITIONAL 1-2 CM OF TUBING EXTENDING BEYOND THE DAMAGE ON EITHER SIDE WAS THEN CUT. A FRESH NO. 11 SURGICAL SCALPEL WAS USED TO MAKE A LENGTHWISE CUT DOWN ONE SIDE OF THE CATHETER TUBING, OPENING THE CATHETER SO IT COULD BE SLIPPED OVER THE DAMAGED AREA. THE CUT CATHETER WAS THEN DELICATELY PLACED AROUND THE DAMAGED SHEATH AND SECURED AT MULTIPLE POINTS WITH CIRCUMFERENTIAL 2-0 SILK TIES UNTIL THERE WAS NO LONGER A BEND IN THE LEAD OR EXPOSED INNER ELECTRODE WIRES. CYANOACRYLATE GLUE WAS THEN INTRODUCED INTO THE OPEN SIDE OF THE CUT CATHETER AS A SEALANT IN AND AROUND THE DAMAGED EXTERNAL INSULATION, UP TO EITHER END OF THE REPAIR. THE GLUE WAS THEN ALLOWED TO FULLY DRY. AT THIS POINT, THE REPAIRED SEGMENT WAS HANDLED IN A SIMILAR FASHION TO THE UNDAMAGED WIRING AND REIMPLANTED. IT WAS NOTED THAT ONE PATIENT HAD SOME INTERNAL WIRING EXPOSED. FOR THIS PATIENT, THE PHYSICIAN PERFORMED THE SAME STEPS FOR THE INTERNAL WIRING AND THEN PERFORMED THE STEPS AGAIN FOR THE EXTERNAL WIRING. FOLLOW UP FOR THE PATIENTS RANGED FROM 12 TO 87 MONTHS. ALL 6 PATIENTS HAVE MAINTAINED UNCHANGED SEIZURES CONTROL. TWO OF THE PATIENTS HAVE SINCE UNDERGONE GENERATOR REPLACEMENT SURGERY DUE TO END OF VNS GENERATOR BATTERY LIFE. BOTH OF THE PATIENTS REMAIN WITH THE ORIGINAL REPAIRED LEADS AND UNCHANGED APPROPRIATE LEAD IMPEDANCE. ONE OF THE PATIENTS WILL BE REPORTED WITHIN THIS MFR. REPORT. THE REMAINING 5 PATIENTS WITHIN THE ARTICLE WERE REPORTED IN THE FOLLOWING MFR. REPORTS: 1644487-2012-00030; 1644487-2012-00043; 1644487-2016-02421; 1644487-2016-02430; 1644487-2016-02431. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    THE PATIENT REPRESENTED WITHIN MFR. REPORT 1644487-2016-02421 IS CONSISTENT WITH THE PATIENT REPRESENTED BY CASE # 1 WITHIN THE ARTICLE. THE PATIENT REPRESENTED WITHIN MFR. REPORT 1644487-2012-00043 IS CONSISTENT WITH THE PATIENT REPRESENTED IN THE ARTICLE BY CASE #2. THE PATIENT REPRESENTED WITHIN MFR. REPORT 1644487-2012-00030 IS CONSISTENT WITH THE PATIENT REPRESENTED IN THE ARTICLE BY CASE #4. THE PATIENT REPRESENTED WITHIN MFR. REPORT 1644487-2016-02431 IS CONSISTENT WITH THE PATIENT REPRESENTED IN THE ARTICLE BY CASE #3. THE PATIENT REPRESENTED WITHIN THIS MFR. REPORT IS CONSISTENT WITH THE PATIENT REPRESENTED IN THE ARTICLE BY CASE #5. THE PATIENT REPRESENTED WITHIN MFR. REPORT 1644487-2016-02430 IS CONSISTENT WITH THE PATIENT REPRESENTED IN THE ARTICLE BY CASE #6.

    Description of Event or Problem · 1

    THE ARTICLE REPORTED THE REASON FOR REVISION FOR THE PATIENT RELATED TO CASE #5 WAS DUE TO INCREASED SEIZURES AND BATTERY DEPLETION. IT WAS NOTED PRIOR TO SURGERY, THE PATIENT HAD NORMAL IMPEDANCE TESTING, BUT WAS FOUND DURING THE COURSE OF THE SURGERY TO HAVE FRACTURED INSULATION AND UNDERWENT THE LEAD REPAIR PROPHYLACTICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697753 LEAD MODEL UNKNOWN LEAD LYJ CYBERONICS, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention