BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOCARE BLADDER SYSTEM

    MDR report key: 380170 · Received March 1, 2002

    Report

    Report Number
    1530440-2002-00003
    Event Type
    Injury
    Date Received
    March 1, 2002
    Report Date
    February 28, 2002
    Manufacturer
    NEUROCONTROL CORP
    Product Code
    GZC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2002, THIS PT REPORTED THAT BATTERIES IN VOCARE BLADDER SYSTEM ECU REQUIRE CHARGING MORE FRQUENTLY THAN WEEKLY, AND THAT PT HAD NOT OBSERVED "NORMAL LEG MOVEMENT" FOR MORE THAN ONE MONTH. THE PT ALSO REPORTED SOME SPINAL DEFORMITY, AND THAT PT WAS TAKING SEVERAL PAIN MEDICATIONS. THE ECU WAS RETURNED AND TESTED, AND DOES NOT APPEAR TO HAVE MALFUNCTIONED, AND A REPLACEMENT DEVICE SHOWED SIMILAR RESULTS. SUBSEQUENT INFO RECEIVED FROM A CONSULTING UROLOGIST INDICATES THAT THIS PT EXPERIENCED SPINAL DISLOCATION OF L1 AND L2 AND THAT PT VOCARE DEVICE IS NOT PRODUCING VOIDING, PROBABLY DUE TO NERVE COMPRESSION RENDERING THE NERVES UNRESPONSIVE TO STIMULATION. THE PT HAD FIXATION HARDWARE REMOVED A CONSIDERABLE TIME BEFORE IMPLANTATION OF THE VOCARE SYSTEM, AND THE DISCLOCATION HAS BEEN ATTRIBUTED PRIMARILY TO THE HARDWARE REMOVAL. HOWEVER, THE LAMINECTOMY FOR THE RHIZOTOMY PROCEDURE THAT IS PERFORMED IN CONJUCNTION WITH DEVICE IMPLANTATION MAY HAVE CONTRIBUTED TO THE SPINAL INSTABILITY RESULTING IN THE DISLOCATION. FOLLOW UP INFO WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOCARE BLADDER SYSTEM IMPLANTABLE STIMULATOR FOR BLADDER EVACUATION GZC NEUROCONTROL CORP 1635-1 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention