BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3851541 · Received June 5, 2014

    Report

    Report Number
    3004209178-2014-10184
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Report Date
    May 16, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3058, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3889-28, LOT# VA0J96Z, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 8840, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THEY DID A NEW IMPLANT LAST FRIDAY, THE FIRST INS THEY TRIED HAD IMPEDANCE PROBLEMS. OVER HALF THE CONTACTS WERE BLANK. THEY WIPED OFF AND RECONNECTED LEAD AND STILL IMPEDANCE PROBLEMS. DIFFERENT CONTACTS WERE SHOWING UP BLANK EACH TIME. THERE WAS NO VISIBLE PROBLEM IN CONNECTOR. THEY TRIED DIFFERENT IMPLANTABLE NEUROSTIMULATOR (INS) AND EVERYTHING WORKED FINE. THE DOCTOR COMPLETED THE CASE AND THE PATIENT WAS DOING WELL. THERE WERE NO OTHER COMPLAINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328678 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR