BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3243653 · Received July 23, 2013

    Report

    Report Number
    3004209178-2013-12202
    Event Type
    Injury
    Date Received
    July 23, 2013
    Report Date
    July 19, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28 LOT# VA07HNZ, IMPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD PRODUCT ID NEU_UN KNOWN_PROG, PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS POOR COMMUNICATION AND THE PATIENT WAS UNABLE TO MAKE ADJUSTMENTS BOTH WITH OR WITHOUT THE ANTENNA ATTACHED. THE REPORTER INDICATED THAT THE PATIENT PROGRAMMER TRAINING WAS MINIMAL OR INEFFECTIVE. IT WAS NOTED THAT THE INABILITY TO ADJUST STIMULATION MAY HAVE BEEN DUE TO POCKET SWELLING. SEVERAL ATTEMPTS WERE MADE TO SYNC WITH THE IMPLANTABLE NEUROSTIMULATOR (INS) BUT THE REPORTER CONTINUED TO GET THE POOR COMMUNICATION SCREEN. IT WAS ALSO INDICATED THAT THE PATIENT EXPERIENCED NO STIMULATION SENSATION. THE REPORTER ALSO STATED THAT THE PATIENT NEVER HAD THE RAPEUTIC EFFECT. THE PATIENT WAS REPORTEDLY ¿URINATING TOO MUCH¿ AND SHE NEEDED TO USE PADS AND WAS WET ¿DAY AND NIGHT¿. THE REPORTER NOTED THAT THE DAY AFTER THE PATIENT WAS IMPLANTED, THE PATIENT¿S HEALTHCARE PROVIDER (HCP) ¿MODULATED HER INS AND MADE ADJUSTMENT TO STIMULATION." WHEN THE PATIENT WAS RETURNING HOME, SHE REPORTEDLY FELT AN "OVERSTIMULATION" FEELING. THE PATIENT COULDN¿T HOWEVER RECALL THAT HAPPENING. IT WAS NOTED THAT THE PATIENT WAS SCHEDULED FOR AN APPOINTMENT WITH HER HCP ON (B)(6) 2013. IT WAS LATER REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS WITH DEVICE OR THERAPY BUT WAS WORKING WITH A MANUFACTURER'S REPRESENTATIVE OR HCP. IT WAS NOTED THAT THE PATIENT WAS SCHEDULED FOR AN APPOINTMENT IN (B)(6). ADDITIONAL INFORMATION RECEIVED REPORTED, THE PATIENT WAS URINATING AT NIGHT, HAD A RETURN OF SYMPTOMS, AND LOSS OF THERAPEUTIC EFFECT. IT WAS NOTED, THE PATIENT WAS CURRENTLY ON PROGRAM 2 AT 1.3 AND WAS ABLE TO TURN STIMULATION UP TO 1.5, BUT STIMULATION WAS THEN UNCOMFORTABLE. IT WAS FURTHER NOTED, THE PATIENT SWITCHED TO PROGRAM 3 SET AT 1.3 AND STIMULATION WAS COMFORTABLE. IT WAS NOTED, THE PATIENT WOULD STAY ON PROGRAM 3 AND TRACK THEIR SYMPTOMS. THE REPORTER STATED, THE PATIENT NEEDED TO KNOW HOW TO TURN ON AND LOWER STIMULATION. THE REPORTER FURTHER STATED, THE PATIENT ¿WAS KIND OF FLIGHTY, BUT IF YOU WERE LOOKING AT HER YOU WOULD KNOW SHE DIDN¿T NEED TO INCREASE IT.¿ IT WAS NOTED, THE PATIENT SAW THEIR HCP TWICE TO HAVE STIMULATION INCREASED. IT WAS FURTHER NOTED, THE PATIENT WAS ¿HALLUCINATING¿ AND URINATING IN THEIR BED AT NIGHT WHEN THE PATIENT DID NOT DO THIS BEFORE IMPLANT. THE REPORTER STATED, THE PATIENT ¿MENTALITY WAS WAY WORSE¿ SO THEY WANT TO HAVE THE STIMULATION LOWERED. THE REPORTER FURTHER STATED, THE PATIENT DID NOT HAVE A RETURN OF SYMPTOMS; THE SYMPTOMS WERE DUE TO THE IMPLANT AND THE INCREASE IN STIMULATION MADE THE PATIENT URINATE. IT WAS NOTED, THE REPORTER STATED THAT IF STIMULATION WAS LOWERED, THE PATIENT WOULD NOT BE URINATING AND LOSING ELECTROLYTES AND THEY WOULD REGAIN THEIR MEMORY. IT WAS NOTED PRIOR TO IMPLANT, THE PATIENT WAS NOT URINATING AS MUCH. IT WAS NOTED, THE PATIENT WANTED TO TURN STIMULATION UP TO HELP CONTROL THEIR SYMPTOMS. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS NOTED THAT THE PATIENT'S MEMORY WAS "WAY WORSE". IT WAS NOTED THAT THE PATIENT WAS SEEING A QUESTION MARK SCREEN ON THEIR PROGRAMMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343722 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Other