BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4764827 · Received May 12, 2015

    Report

    Report Number
    3004209178-2015-08904
    Event Type
    Malfunction
    Date Received
    May 12, 2015
    Report Date
    April 22, 2015
    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
    IN, 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# V223177, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT COULD NOT MAKE ADJUSTMENTS WITH HIS PATIENT PROGRAMMER. THERE WAS POOR COMMUNICATION. THE PATIENT CHANGED THE BATTERIES, TRIED WITH AND WITHOUT THE ANTENNA, AND THE PATIENT PROGRAMMER HAD NOT BEEN DROPPED OR WET. THERE WERE NEW ALKALINE BATTERIES INSIDE OF IT. SINCE ABOUT A MONTH AND A HALF PRIOR TO THE REPORT, THE PATIENT STARTED GOING TO THE BATHROOM MORE AND HAD NOT BEEN EMPTYING. AROUND THE SAME TIME, THE PATIENT FELL DOWN THE STEPS ON HIS TAILBONE. THE PATIENT HAD PROSTATE SURGERY PRIOR TO GETTING HIS IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT RECEIVED A REPLACEMENT PATIENT PROGRAMMER AND ALSO HAD NOT BEEN ABLE TO COMMUNICATE. THE PATIENT WAS GOING TO FOLLOW UP WITH HIS HEALTH CARE PROFESSIONAL (HCP) BECAUSE IT WAS UNLIKELY THAT HIS INS BATTERY WAS DEPLETED. THERE WAS AN APPOINTMENT SCHEDULED WITH THE HCP. NO OUTCOME OR INTERVENTION WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309781 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR