BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4929450 · Received July 21, 2015

    Report

    Report Number
    3004209178-2015-13791
    Event Type
    Malfunction
    Date Received
    July 21, 2015
    Date of Event
    April 3, 2015
    Report Date
    August 20, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3 889-33, LOT# VA0NBQS, IMPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM THE HEALTH CARE PROFESSIONAL REPORTED THE PATIENT HAD AN MRI BRAIN SCAN. HE WAS SEEN FOR REPROGRAMMING AND TO CONFIRM THERE WAS NO DEVICE MALFUNCTION AFTER THE MRI. ON (B)(6) 2015, THE PATIENT WAS SEEN FOR REPROGRAMMING AND IMPEDANCE CHECK. THE IMPEDANCES WERE WITHIN NORMAL RANGE AND THE PATIENT'S PROGRAM WAS CHANGED. THE PATIENT WENT ON TO TRY THE NEW PROGRAM AND WILL NOTE THE EFFECT 2 WEEKS AFTER REPORT. IT WAS NOTED THAT BASED ON THE PATIENT'S "PMW," HE WAS SEEING OVER A 50% THERAPEUTIC EFFECT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD AN MRI ON (B)(6) 2015 AND EVER SINCE THEN, THE PATIENT HAD A SUDDEN LOSS OF THERAPY AND RETURN OF SYMPTOMS. HE WAS LEAKING ALL DAY LONG. THE REPORTER DIDN'T RECALL ANY POWER ON RESET (POR) MESSAGES, BUT IT MIGHT HAVE BEEN OFF. THE REPORTER THOUGHT THERE WAS AN INCREASE TO STIMULATION TWICE, BUT WASN'T SURE IF IT WAS DONE RIGHT. THE REPORTER PLANNED TO FOLLOW UP WITH THE PATIENT'S HEALTHCARE PROVIDER. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473809 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00089 YR