BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2172670 · Received July 20, 2011

    Report

    Report Number
    1644487-2011-01627
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    May 25, 2011
    Report Date
    June 23, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    MFR REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY THE MFR, NO GROSS LEAD DISCONTINUITIES VISUALIZED. DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REVEALED THAT THE PATIENT HAS NOT ACHIEVED THE SAME EFFICACY SINCE THIS CURRENT GENERATOR WAS IMPLANTED IN THAT SINCE SURGERY IN 2009, THE PATIENT HAS EXPERIENCED A SLOW GRADUAL INCREASE IN SEIZURE FREQUENCY. THERE WERE NO REPORTS OF TRAUMA OR MANIPULATION AND THE PATIENT IS TENTATIVELY SCHEDULED FOR REVISION SURGERY LATER THIS MONTH.

    Description of Event or Problem · 1

    PRODUCT ANALYSIS OF THE EXPLANTED LEAD AND GENERATOR HAS BEEN COMPLETED. DURING ANALYSIS OF THE LEAD, PUNCTURE AND SLICE MARKS WERE FOUND ON THE OUTER SILICONE TUBING WHICH PROVIDED A LEAKAGE PATH FOR WHAT APPEARED TO BE REMNANTS OF DRIED BODY FLUIDS FOUND INSIDE THE OUTER SILICONE TUBING. THE CONDITION OF THE RETURNED LEAD PORTIONS IS CONSISTENT WITH CONDITIONS THAT TYPICALLY EXIST FOLLOWING AN EXPLANT PROCEDURE. NO OBVIOUS ANOMALIES WERE NOTED. THE RESISTANCE MEASUREMENT TAKEN DURING DECONTAMINATION VERIFIED AN ELECTRICAL AND MECHANICAL CONTACT BETWEEN THE GENERATOR AND CONNECTOR PIN AT ONE POINT IN TIME. CONTINUITY CHECKS OF THE RETURNED LEAD PORTIONS WERE PERFORMED, DURING THE VISUAL ANALYSIS, WITH NO DISCONTINUITIES IDENTIFIED. BASED ON THE FINDINGS IN THE PRODUCT ANALYSIS LAB, THERE IS NO EVIDENCE TO SUGGEST AN ANOMALY WITH THE RETURNED PORTIONS OF THE DEVICE WHICH MAY HAVE CONTRIBUTED TO THE STATED COMPLAINTS. NOTE THAT SINCE THE ELECTRODE ARRAY SECTION WAS NOT RETURNED FOR ANALYSIS, AN EVALUATION AND RESULTING COMMENTARY CANNOT BE MADE ON THAT PORTION OF THE LEAD. DURING ANALYSIS OF THE EXPLANTED GENERATOR, IT WAS NOTED THAT THE SEPTUM WAS NOT CORED THUS ELIMINATING THE POSSIBILITY OF A POTENTIAL UNINTENDED ELECTRICAL CURRENT PATH THROUGH THE BODY FLUIDS (ADDRESSING THE ALLEGATIONS OF PAIN AND PAINFUL STIMULATION). THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A NEUROLOGIST THAT VNS PT HAD INCREASE IN SEIZURES AND COULD NOT PERCEIVE STIMULATION. DIAGNOSTICS WERE WITHIN NORMAL LIMITS. PT'S SEIZURE ACTIVITY HAS NOT CHANGED SINCE THE LAST OFFICE VISIT ON (B)(6) 2011. PT'S MOTHER SAID THAT THE PT NO LONGER COUGHED LIKE SHE USED TO. PT STOPPED FEELING STIMULATION ABOUT 2 - 3 MONTHS AGO, DESPITE THE INCREASE IN SETTINGS ON (B)(6) 2011. THE SETTINGS WERE FURTHER INCREASED TO 2MA ON (B)(6) 2011 BUT PT STILL WAS NOT ABLE TO PERCEIVE STIMULATION. THE TREATING NEUROLOGIST STATED THAT HE SAW A DCDC = 0 WHEN HE PERFORMED SYS DIAGNOSTICS AND WAS CONCERNED ABOUT A SHORT CIRCUIT AND PT NOT FEELING STIMULATION. THUS, PT WILL LIKELY BE REFERRED FOR SURGERY. X-RAYS WERE TAKEN AND REVIEWED BY THE MFR. GENERATOR PLACEMENT APPEARED NORMAL. THE LEAD CONNECTOR PIN APPEARED TO BE COMPLETELY INSERTED INTO THE GENERATOR CONNECTOR BLOCK. THE GENERATOR FEED-THROUGH WIRES APPEARED TO BE INTACT. THE ELECTRODES APPEARED TO BE IN PROPER ALIGNMENT. NO GROSS FRACTURE OR LEAD DISCONTINUITIES COULD BE VISUALIZED ON THE LEAD PORTION ASSESSED, HOWEVER, THERE WAS A SUSPICIOUS AREA NOTED IN THE BEND CAUDAL TO ELECTRODES, BUT CANNOT BE CONFIRMED DUE TO A LACK OF CLEAR LATERAL VIEW OF THE CHEST. THERE WAS A PORTION OF THE LEAD BODY BEHIND THE GENERATOR THAT WAS UNABLE TO BE ASSESSED. ADDITIONALLY, THE PREVIOUSLY PLACED ELECTRODES AND A SMALL PORTION OF THE LEAD BODY WERE STILL PRESENT. THE LOCATION OF THIS PORTION OF THE DEVICE WAS CEPHALAD TO THE MOST RECENT LEAD BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 200994

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention| R
    1 35 YR Female Required Intervention| R