BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4756076 · Received May 7, 2015

    Report

    Report Number
    3004209178-2015-08637
    Event Type
    Injury
    Date Received
    May 7, 2015
    Report Date
    April 15, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT # V896806, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3889-28, LOT # V896806, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD THE IMPLANT 2 YEARS AGO BUT DIDN¿T GET THERAPY. THE PATIENT HAD PROBLEMS ALMOST IMMEDIATELY THE FIRST YEAR AND HAD 2 PROGRAMS AND THEN 0. THE PATIENT¿S BACK WAS SORE AND THEY COULDN¿T SIT BACK DUE TO THE SYSTEM. THE HEALTH CARE PROVIDER (HCP) REMOVED IT IN (B)(6) 2014 AND AT THE TIME OF REMOVAL THE PATIENT WAS TOLD 1 ELECTRODE WAS WORKING. THE MANUFACTURER REPRESENTATIVE WAS UNSURE IF THERE WAS AN IMPEDANCE ISSUE OR NOT. THE HCP TOLD THE PATIENT THEY SENT THE DEVICE IN, BUT THE DEVICE WAS NOT RECEIVED BY THE MANUFACTURER. THE HCP TOLD THE PATIENT THEY NEEDED TO SEND IT IN AND THE PATIENT HAD REQUESTED THEY GIVE IT TO THEM AND THE HCP SAID THEY COULDN¿T. THE PATIENT ALREADY TALKED TO THEIR HCP. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. ADDITIONAL INFORMATION COULD NOT BE OBTAINED AT THE TIME OF THE REPORT.  SHOULD ADDITIONAL INFORMATION BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300377 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention