BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NCP PULSE GENERATOR

    MDR report key: 456797 · Received April 25, 2003

    Report

    Report Number
    1644487-2003-00208
    Event Type
    Injury
    Date Received
    April 25, 2003
    Date of Event
    December 1, 1998
    Report Date
    March 28, 2003
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT PATIENT'S NCP SYSTEM WAS EXPLANTED DUE TO SLEEP APNEA. FURTHER FOLLOW-UP REVEALED THAT IN 2003 DURING SURGICAL CONSULT FOR NCP SYSTEM EXPLANT, THE PATIENT INDICATED THAT THEY FELT AS IF THEIR THROAT WAS CLOSING DOWN WITH STIMULATION, BUT THAT THEY HAD TOLERATED IT BECAUSE THEY HAD BEEN DOING WELL REGARDING THEIR SEIZURES WITH THE VNS THERAPY. THE PATIENT INDICATED THAT THEIR SYMPTOMS HAD WORSENED AND THEIR PROGRAMMED PARAMETERS WERE GRADUALLY REDUCED TO THE POINT THAT THE DEVICE HAD BEEN PROGRAMMED TO OFF SINCE 2002. THE PATIENT INDICATED THAT THE CLOSING OF THEIR THROAT HAD IMPROVED SINCE PROGRAMMING THE DEVICE TO OFF. ADDITIONALLY, THE PATIENT INDICATED THAT THEY HAD A SENSATION OF FOOD GETTING STUCK IN THEIR ESOPHAGUS WHEN THEY EAT WHICH WAS ALSO WORSE WHEN THE DEVICE WAS PRGRAMMED TO ON. AS OF 2003, THE PATIENT HAD REPORTEDLY HAD NO SEIZURES IN THE PAST TWO OR THREE MONTHS. THE PATIENT REPORTED THAT THEIR BREATHING WAS BETTER SINCE PROGRAMMING THE DEVICE TO OFF. THE PATIENT HAD REPORTEDLY REQUESTED REMOVAL OF THE NCP SYSTEM FOR DIFFICULTY SWALLOWING. NEUROSURGEON INDICATED THAT HE WAS UNSURE WHETHER THE NCP SYSTEM WAS INVOLVED IN THE PATIENT'S SWALLOWING PROBLEM AND REQUESTED A GI WORK-UP AND A SWALLOWING STUDY TO LOOK FOR DYSMOTILITY AND POSSIBLE DIVERTICULUM PRIOR TO EXPLANT SURGERY FOR CLARIFICATION OF THE PATIENT'S SWALLOWING PROBLEM. INVESTIGATION TO DATE HAS BEEN UNABLE TO DETERMINE WHETHER THE AFOREMENTIONED TESTS WERE PERFORMED. THE PATIENT'S NCP SYSTEM WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCP PULSE GENERATOR PULSE GENERATOR LYJ CYBERONICS, INC. 100 9623C

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R| S LOT NO. 9895C.| MODEL 300-20 NCP BIPOLAR LEAD, EXPIR DATE| LAMICTAL - 200, 2BID| 04/30/2000, DATE OF MFG 04/15/1998, STERILIZATION| CURRENT MEDICATIONS: