BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4792696 · Received May 22, 2015

    Report

    Report Number
    3004209178-2015-09604
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Report Date
    April 30, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID: NEU_UNKNOWN_LEAD, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT¿S STIMULATION TURNED OFF AND SHE THOUGHT IT COULD BE CONNECTED TO GOING THROUGH THEFT DETECTORS FOUND AT RETAIL STORES, AS SHE NOTED THAT SOME OF THE OCCURRENCES HAPPENED AFTER SHE HAD GONE SHOPPING. THE ISSUE BEGAN IN (B)(6) AND THE DEVICE HAD BEEN TURNED ON DURING EXPOSURE. THE PATIENT¿S HEALTHCARE PROVIDER INSTRUCTED HER TO CONTACT THE MANUFACTURER DUE TO THE DEVICE NOT STAYING ON. SHE WAS INSTRUCTED TO CONTACT THE HEALTHCARE PROVIDER OFFICE BACK IF THE MANUFACTURER HAD NOT HELPED HER, AND SHE HAD NOT CALLED BACK. 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
    333993 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1