BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 5150675 · Received October 14, 2015

    Report

    Report Number
    3004209178-2015-20626
    Event Type
    Injury
    Date Received
    October 14, 2015
    Report Date
    September 15, 2014
    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
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# V842736, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. THE PATIENT STATED THEY WERE HAVING PROBLEMS WITH THEIR DEVICE AND IT WAS NOT WORKING CORRECTLY. THE PATIENT NOTED THEIR CURRENT MANAGING HEALTHCARE PROVIDER DIDN'T WANT TO MESS WITH IT. THE PATIENT STATED IT'S NOT WORKING AND THEY GO TO THE BATHROOM. THE PATIENT WENT UP ONE DAY AND THEIR NURSE SHOWED THEM HOW TO SET IT UP, SHE SET IT UP, THE PATIENT CAME HOME AND THEY WOULD GO TO THE BATHROOM, BUT JUST A LITTLE BIT AND THEN THEY HAD TO CATHETERIZE THEMSELVES. THE PATIENT'S ISSUES HAD BEEN GOING ON FOR ABOUT A MONTH. INFORMATION RECEIVED LATER ON (B)(6) 2014 INDICATED THAT PATIENT WAS STILL HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT WAS WORKING WITH THE HEALTHCARE PROVIDER OR MANUFACTURER REPRESENTATIVE. THE PATIENT ALSO MENTIONED THAT THEY DO HAVE CONCERNS BUT HAVE NOT SOUGHT FURTHER HELP. THE PATIENT APPOINTMENT WAS SCHEDULED FOR (B)(6) 2014 RECENTLY. ADDITIONAL INFORMATION RECEIVED ABOUT COUPLE MONTHS LATER REPORTED THAT THE DEVICE HAD NEVER WORKED IN CONTROLLING THE PATIENT'S SYMPTOMS. IT WAS NOTED THEY WERE GETTING UP ABOUT EVERY HALF HOUR TO EVERY HOUR. THE PATIENT WAS CURRENTLY ON PROGRAM 2 AT 1.0V. THEY INCREASED STIMULATION TO 1.4V WHICH WAS TOO STRONG SO THEY DECREASED TO 1.3V, WHICH WAS STRONG AND COMFORTABLE. THE PATIENT WAS GOING TO LEAVE IT AT THE CURRENT SETTING AND TRACK THEIR SYMPTOMS. PATIENT WAS INDICATED FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION. NO OUTCOME WAS PROVIDED WITH THIS EVENT. FURTHER FOLLOW UP IS BEING CONDUCTED TO OBTAIN ADDITIONAL INFORMATION. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678479 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Other