BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2925477 · Received January 22, 2013

    Report

    Report Number
    3004209178-2013-00835
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Report Date
    January 3, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3093-28, LOT# V855059, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT DAYTIME STIMULATION FOR A PATIENT WAS WORKING GREAT, BUT "IF SHE HELD AND WAITED TOO LONG, SHE WOULD WET HERSELF." IT WAS STATED THAT DURING THE NIGHT TIME, HER BLADDER COULD ONLY HOLD FOR 4 HOURS AND THEN "HER PAD WOULD BE COMPLETELY SOAKED." THIS HAD NOT CHANGED SINCE THE TIME OF IMPLANT. TWO OTHER PROGRAMS WERE TRIED AND THE PATIENT WAS CURRENTLY ON PROGRAM 3 AT 4.2V FOR THE PAST MONTH. IT WAS ALSO INITIALLY REPORTED THAT THE PATIENT REPORTED THAT THEY STILL HAD CONCERNS, BUT HAD NOT SOUGHT FURTHER HELP. MORE PATIENT EDUCATION WAS RECOMMENDED PRIOR TO PROCEDURE INSTEAD OF "POST-OP WHEN THE PATIENT WAS STILL SEDATED." IT WAS STATED THAT THE CAUSE OF THE EVENT WAS BLADDER SPASM. ABNORMAL IMPEDANCES WERE REPORTED BETWEEN ELECTRODES 0 AND 3, <(><<)> 50 OHMS. HOWEVER, THESE ELECTRODES WERE NOT IN ANY OF PATIENT'S PROGRAMS. REPROGRAMMING WAS PERFORMED ON (B)(6) 2013, AND "IT WAS LEFT ON -0 AND -2." SENSATION IN PERINEUM WAS NOTED. ENURESIS WAS STATED AS A SIGN/SYMPTOM. IT WAS NOTED THAT THE PATIENT "AT TIMES HAD ATTEMPTED TO CHANGE PROGRAMS AND INADVERTENTLY CUT IT OFF." NO HOSPITALIZATION AND NO PATIENT INJURY WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29753 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1