BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4100020 · Received September 18, 2014

    Report

    Report Number
    3004209178-2014-17334
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 26, 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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT # VA0CVDM, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD NOT HAD ANY ISSUES WITH THE DEVICE OR THERAPY UNTIL THE DAY OF THE REPORT. THE DEVICE STARTED ACTING UP, THERE WAS NO STIMULATION SENSATION, AND THERE WAS A LOSS OF THERAPEUTIC EFFECT. THE PATIENT HAD A LOSS OF BLADDER CONTROL AND THE SYMPTOMS WERE LOCATED AT THE PERINEUM. THE DEVICE ¿JUST QUIT¿ AND WHEN THE PATIENT WAS AT THE STORE ALL OF THE SUDDEN HER BLADDER LET GO, THERE WAS AN INTERRUPTION IN THERAPY AND SHE WAS WET EVERYWHERE. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THE COMPLAINT, ALTHOUGH THE PATIENT DID GO THROUGH A SECURITY DEVICE AT THE LIBRARY. THE PATIENT DIDN¿T DO ANYTHING WITH THE PATIENT PROGRAMMER OR TURN OFF THE IMPLANTABLE NEUROSTIMULATOR (INS) AND IT WAS IN THE PATIENT¿S PURSE. THE PATIENT PROGRAMMER SCREEN SHOWED TO SYNC WITH THE INS AND SHOWED THAT THE PROGRAMMER BATTERIES WERE LOW. THE PROGRAMMER BATTERIES WERE REPLACED AND THE PROGRAMMER WAS ABLE TO SYNC WITH THE INS. THE INS WAS ON AT 2.1. 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
    578451 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR