BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4863836 · Received June 23, 2015

    Report

    Report Number
    3004209178-2015-12097
    Event Type
    Injury
    Date Received
    June 23, 2015
    Date of Event
    February 11, 2015
    Report Date
    June 4, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-33, LOT# VA0S6U3, IMPLANTED: 2015 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3037, SERIAL# (B)(6); PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS RETURN OF SYMPTOMS AND 2 URINARY TRACT INFECTIONS (UTI¿S). THE PATIENT HAD NO PROBLEM WITH CONTROLLING HER SYMPTOMS DURING THE DAY BUT SHE COULD NOT AT NIGHT. SHE SPOKE TO HER PHYSICIAN REGARDING THE SYMPTOMS NOT BEING CONTROLLED BUT SHE WAS TOLD TO CALL HER DEVICE MANUFACTURER. AT THE TIME OF REPORT, SHE WAS ON PROGRAM 1 AT 2.0 AND SHE COULD FEEL STIMULATION. SHE INCREASED STIMULATION TO 2.1 WHICH WAS COMFORTABLE SITTING, STANDING AND WALKING. PATIENT WAS AWARE THAT IF STIMULATION BECAME TOO STRONG, SHE WOULD DECREASE IT. THE PATIENT DID NOT RECEIVE THE THERAPY GUIDE. PROGRAM 4 GAVE HER PAIN AND SHE CHANGED IT. SHE WAS ON TOVIAZ WHICH SHE WAS TAKING AT THE TIME OF REPORT; SHE WAS ALSO PUTTING GELNIQUE WHICH IS RUBBED INTO THE THIGH TO HELP WITH HER INCONTINENCE. THE PATIENT¿S SYMPTOMS WERE GETTING WORSE AT NIGHT. IT WAS NOTED THAT THE PATIENT HAD A COUPLE OF UTIS PRIOR TO IMPLANT AND A COUPLE OF UTI¿S SINCE IMPLANT. SHE HAD A UTI IN (B)(6) PRIOR TO REPORT, SHE WAS ON ANTIBIOTICS FOR 10 DAYS AND IT WENT AWAY. SHE HAD ANOTHER UTI. SHE WAS THE DOCTOR AND SHE WAS PUT ON ANTIBIOTICS FOR ANOTHER 10 DAYS UNTIL IT WENT AWAY. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOL LOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406126 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Required Intervention