BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2982595 · Received February 28, 2013

    Report

    Report Number
    3004209178-2013-03143
    Event Type
    Injury
    Date Received
    February 28, 2013
    Report Date
    February 14, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3889-28, LOT#: VA0406G, PRODUCT TYPE: LEAD; PRODUCT ID: 3037, SERIAL#: UNKNOWN, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LOSS OF THERAPEUTIC EFFECT. THE REPORTER STATED THAT THE PATIENT WENT TO THE BATHROOM 4-5 TIMES AT NIGHT AND USED TO GO ABOUT 8 TIMES. IT WAS REPORTED THAT THE PATIENT WENT TO THE BATHROOM ABOUT 9-10 TIMES DURING THE DAY. IT WAS NOTED THAT PROGRAM 1 WAS AT 1.9 VOLTS AND WAS INCREASED TO 2.3 VOLTS AND THE PATIENT WAS NOT FEELING STIMULATION. IT WAS REPORTED THAT THE PATIENT SOMETIMES FELT A WAVE OF IMPULSES WHEN STANDING AND THE PATIENT WAS NOT FEELING THE SENSATION AS BEFORE. FIVE DAYS LATER, IT WAS REPORTED THAT THERE WAS DIFFICULTY OPERATING THE PATIENT PROGRAMMER DUE TO ITS COMPLEXITY. TWO MONTHS LATER, IT WAS REPORTED THAT THE CAUSE OF THE EVENT WAS THAT THE PATIENT DIDN'T KNOW HOW TO USE THE PATIENT PROGRAMMER. STIMULATION WAS INCREASED AT NIGHT AND DECREASED DURING THE DAY. IT WAS NOTED THAT REPROGRAMMING WAS DONE ON (B)(6) 2013 AND THE PULSE WIDTH AND SOME OF THE STIMULATION PARAMETERS WERE CHANGED. THERE WAS NO INJURY TO THE PATIENT. IT WAS FURTHER REPORTED THAT THE PATIENT WAS GETTING UP TO VOID 2-3 TIMES PER NIGHT DOWN FROM 5-6, BUT DIDN'T NOTICE A FREQUENCY DURING THE DAY. IT WAS NOTED THAT THE PATIENT WONDERED IF THE DEVICE TURNED ITSELF OFF DURING THE DAY OR TURNED ITSELF OFF BASED ON POSITIONING. THE REPORTER STATED THAT THE PATIENT WAS RECENTLY TREATED WITH CIPROFLOXACIN AND BACTRIM FOR A URINARY TRACT INFECTION. THE DIAGNOSIS WAS BASED ON URINALYSIS. IT WAS NOTED THAT THE PATIENT HAD FINISHED THE ANTIBIOTICS AND HAD A "TINY BIT" OF RESIDUAL DYSURIA. THE REPORTER STATED THAT THE PATIENT WAS USING ESTRACE CREAM TWICE A DAY AND AN ALCOHOL WIPE IN THE VAGINAL AREA. IT WAS REPORTED THAT THE PATIENT DID NOT HAVE A FEVER OR CHILLS OR A CHANGE IN THE LEVEL OF URGENCY. THE PATIENT'S HEALTHCARE PROVIDER DISCUSSED INCREASING STIMULATION TO A POINT WHERE THE PATIENT COULD FEEL IT AND ANOTHER PROGRAM MAY BE TRIED. IT WAS REPORTED THAT EARLIER THE PATIENT HAD ISSUES OF DISCOMFORT AND VAGINAL PAIN. IT WAS NOTED THAT THE PATIENT WAS CONCERNED THAT THE PAIN COULD BE RELATED TO DENTAL IMPLANT WORK, BUT THE PATIENT'S HEALTHCARE PROVIDER STATED THAT IT WAS NOT RELATED. IT WAS NOTED THAT THE IMPLANT SITE WAS "HEALING UP NICELY" WITHOUT EVIDENCE OF INFECTION OR TENDERNESS. THE PATIENT WAS SCHEDULED FOR AN APPOINTMENT WITH HER HEALTHCARE PROVIDER SIX WEEKS AFTER THE REPORT. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89046 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Required Intervention