BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3122595 · Received May 21, 2013

    Report

    Report Number
    3004209178-2013-07984
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 1, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3093-28, LOT # VA06M14, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PATIENT URINATED IT BURNED UP IN THE PATIENT'S VAGINA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A URINARY TRACT INFECTION WHICH BEGAN YESTERDAY. IT WAS NOTED THAT THEY DID NOT FEEL GOOD OVER THE WEEKEND AND KNEW SOMETHING WAS WRONG. THE PATIENT STATED THAT THEY HAD THESE INFECTIONS EVEN BEFORE THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS PLACED. THE PATIENT DID REPORT THAT THE INS THERAPY DID HELP WITH THEIR CATHETERIZATION. THE PATIENT DID INCREASE THE STIMULATION TO 2.1 VOLTS BUT WAS ¿TOO MUCH¿ AND WAS DECREASED TO 1.8 VOLTS WHERE IT WAS NOTED THAT THEY WERE ¿URINATING GREAT¿ SINCE. TWELVE DAYS LATER ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE PATIENT SAW THEIR HEALTHCARE PROFESSIONAL (HCP) ON (B)(6) 2013 AND WAS DIRECTED TO LEAVE THE INS AT 1.8 VOLTS. IT WAS NOTED THAT THE PATIENT DRINKS A LOT OF WATER, JUICES, AND TEA. THE PATIENT NOTICED OVER THE WEEKEND THAT THEY WERE NOT URINATING WELL (¿ONLY DRIBBLES¿). THE PATIENT HAD A ¿PULLING SENSATION¿ BUT NOT AS STRONG AS IT WAS. THE PATIENT WAS TOLD BY THEIR PHYSICIAN THAT THEY HAD A ¿LARGE BLADDER.¿ THE PATIENT REPORTED THAT ON (B)(6) 2013 THEY INCREASED THE STIMULATION TO 2.1 VOLTS AND NOTED THAT THEY NOW COULD GO TO THE BATHROOM, HAD GOOD FLOW, AND HAD A GOOD SENSATION (THEY HAD ALREADY GONE TO THE BATHROOM 3 TIMES TODAY). THE PATIENT ALSO REPORTED THAT THEY HAD AN INFECTION BUT THAT IT HAD CLEARED UP BY THE TIME THEY SAW THEIR HCP. THE PATIENT WAS DUE BACK TO THE HCP¿S OFFICE IN 6 WEEKS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223718 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention