BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 304

    MDR report key: 6288741 · Received January 31, 2017

    Report

    Report Number
    1644487-2017-03110
    Event Type
    Malfunction
    Date Received
    January 31, 2017
    Date of Event
    January 5, 2017
    Report Date
    February 24, 2017
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    OPERATIVE NOTES WERE RECEIVED FROM THE DAY OF SURGERY. PER NOTES, THE LEAD DEMONSTRATED TEAR ALONG THE SUPERFICIAL ASPECT OF THE SILICONE SHEATH. THIS WAS REPAIRED USING INTEGRA VENTRICULAR CATHETER, WHICH WAS APPLIED TO 'THE ELECTRODE TO REINFORCE IT AT ALL AREAS IN WHICH THE OUTER SHEATH APPEARED TO BE TORN. THE SURGEON NOTED THAT THE DISTAL ASPECT OF THE LEAD DEMONSTRATED AN AREA ALONG THE ELECTRODE OF APPROXIMATELY 2-1/2 CM IN WHICH THE OUTER SILICONE SHEATH OF THE ELECTRODE WAS TORN. THE INNER METALLIC WIRES WERE INTACT AND THE INNER SILICON SHEATH ADJACENT TO THE METALLIC WIRES WERE INTACT AS WELL. DUE TO THE CONCERN OF FURTHER BREAKDOWN OF THE ELECTRODE FROM EITHER A KINKING OR FROM THE BODY' REACTION TO THE IMPLANT, A INTEGRA HERMETIC VENTRICULAR # 3/ 4 CATHETER WAS SELECTED, 35 CM LENGTH, 1.3 ROM INNER DIAMETER, 2.5 ROM OUTER DIAMETER. THE CATHETER WAS 'THEN -HELD OPEN ALONG, THE INCISION ENDS AND A WRAPPED AROUND THE ELECTRODE. IT WAS THEN SECURED IN PLACE WITH MULTIPLE #3-0 SILK TIES TO MAINTAIN THE VENTRICULAR CATHETER AROUND THE ELECTRODE SITE AND TO· PREVENT KINKING, WITH THE ELECTRODE AS WELL AS TO ENSURE GOOD, COVERAGE AROUND THE SILICONE SHEATH.

    Description of Event or Problem · 1

    DURING A PROPHYLACTIC GENERATOR REPLACEMENT, THE COMPANY REPRESENTATIVE OBSERVED THE SURGEON PLACE "SOMETHING PLASTIC" AROUND THE LEAD. IT WAS AS IF THE SURGEON WAS TRYING TO REPAIR THE LEAD. THE DIAGNOSTICS PRIOR TO AND AFTER THE GENERATOR REPLACEMENT WAS WITHIN NORMAL LIMITS AND THE REASON FOR THE REPAIR IS UNKNOWN. PER COMPANY REPRESENTATIVE, THE SURGEON WAS WORRIED ABOUT THE LEAD IN SOMEWAY. COMPANY REPRESENTATIVE WAS ABLE TO SEE THE LEAD WHEN PERFORMING DIAGNOSTICS AFTER THE EVENT. PER COMPANY REPRESENTATIVE, IT LOOKED NORMAL AND SHE DID NOT NOTICE ANY OBVIOUS ISSUES. THE SURGEON CLIPPED SOMETHING AROUND THE LEAD (LIKE A TUBE AROUND THE LEAD). THE SURGEON ALSO TOOK PICTURES OF THE LEAD. THE SURGEON DID NOT PROVIDE ANY INFORMATION ON WHAT WAS DONE OR THE REASON. THERE WERE NO REPORTED PROBLEMS WITH THE PATIENT OR LEAD. A REVIEW OF THE PROGRAMMING AND DIAGNOSTIC DATA FOR THE EXPLANTED GENERATOR SHOWS THAT THE DC CODE DROPPED FROM 3 TO 0 IN SYSTEM DIAGNOSTIC TESTS, WHICH MAY BE INDICATIVE OF LOW IMPEDANCE DUE TO A POSSIBLE SHORT CIRCUIT CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72568 LEAD MODEL 304 LEAD LYJ CYBERONICS, INC. 304-20 2767

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR