BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 3132013 · Received May 29, 2013

    Report

    Report Number
    1644487-2013-01598
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 5, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013 IT WAS REPORTED THAT THE VNS PATIENT HAS BEEN EXPERIENCING PAINFUL STIMULATION IN THE NECK WHICH STARTED THE WEEK PRIOR. THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM. THE PATIENT¿S VNS WAS TURNED OFF SOMETIME THE WEEK PRIOR BUT THE PATIENT IS STILL COMPLAINING OF INTERMITTENT PAIN, NOT OCCURRING ALL THE TIME. DIAGNOSTICS WERE PERFORMED AND WERE WITHIN NORMAL LIMITS; SYSTEM DIAGNOSTICS TEST: OUTPUT=OK/LEAD IMPEDANCE=OK/DCDC=2/ERI=NO. ADDITIONALLY, X-RAYS WERE TAKEN BUT THE PHYSICIAN COULD NOT SEE ANYTHING THAT WOULD POINT TO A DEVICE ISSUE. WHEN THE PHYSICIAN DID EKG MONITORING IN THE NECK AREA, SHE SAID THAT SHE OBSERVED A "PEAK" THAT APPEARED TO BE A STIMULATION CYCLE, WHICH COINCIDED WITH THE PATIENT'S PAIN AT THAT TIME, DESPITE THAT THE DEVICE WAS CONFIRMED TO BE PROGRAMMED TO 0.00MA. IT WAS REPORTED THAT THE PATIENT UNDERWENT GENERATOR REPLACEMENT ON (B)(6) 2013 DUE TO THE PAINFUL STIMULATION. IT WAS REPORTED THAT THE EXPLANTED GENERATOR WOULD BE RETURNED FOR PRODUCT ANALYSIS BUT IT HAS NOT BEEN RECEIVED TO DATE. GOOD FAITH ATTEMPTS TO THE PHYSICIAN FOR FURTHER INFORMATION HAVE BEEN UNSUCCESSFUL. A BATTERY LIFE CALCULATION WAS PERFORMED WHICH SHOWED 0.47 YEARS REMAINING UNTIL ERI=YES.

    Description of Event or Problem · 1

    ON (B)(6) 2013 PRODUCT ANALYSIS ON THE EXPLANTED GENERATOR WAS COMPLETED. ALTHOUGH THE SEPTA APPEAR CORED, THERE WAS NO EVIDENCE OF DRIED BODY FLUID OR CORROSION OBSERVED IN THE CONNECTOR BLOCK AREAS, THUS ELIMINATING THE POSSIBILITY OF A POTENTIAL UNINTENDED ELECTRICAL CURRENT PATH THROUGH BODY FLUIDS. IN THE PRODUCT ANALYSIS LAB, THE DEVICE OUTPUT SIGNAL WAS MONITORED FOR MORE THAN 24-HRS, WHILE THE GENERATOR WAS PLACED IN A SIMULATED BODY TEMPERATURE ENVIRONMENT. RESULTS SHOWED NO SIGNS OF VARIATION IN THE PULSE GENERATOR¿S OUTPUT SIGNAL AND DEMONSTRATED THAT THE DEVICE PROVIDED THE EXPECTED LEVEL OF OUTPUT CURRENT FOR THE ENTIRE MONITORING PERIOD. THE PULSE GENERATOR DIAGNOSTICS WERE AS EXPECTED FOR THE PROGRAMMED PARAMETERS. THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. DURING DECONTAMINATION AN ERI MESSAGE WAS OBSERVED. ANALYSIS IN THE PA LAB CONCLUDED PROPER FUNCTIONALITY OF THE PULSE GENERATOR AND THAT NO ABNORMAL PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITION WAS FOUND.

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE EXPLANTED GENERATOR WAS RETURNED FOR PRODUCT ANALYSIS. IT WAS STATED THAT IT HAD BEEN REMOVED DUE TO ¿PAINFUL STIMULATION SHOCKING PATIENT¿. PRODUCT ANALYSIS IS STILL UNDERWAY AND HAS NOT YET BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234907 PULSE GEN MODEL 102R GENERATOR LYJ CYBERONICS, INC. 102R 2258

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other