BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 3922648 · Received July 9, 2014

    Report

    Report Number
    3004209178-2014-12722
    Event Type
    Injury
    Date Received
    July 9, 2014
    Report Date
    June 19, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# J0546213V, IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD; PRODUCT ID 3023, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3889-28, LOT# J0555237V, IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD; PRODUCT ID 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION; PRODUCT ID 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BOTH THE BATTERIES AND LEADS WERE REPLACED IN (B)(6) 2013. IT WAS STATED THAT THE LEADS WERE REPLACED BECAUSE THEY ¿DETERIORATED.¿ THE PATIENT WAS UNSURE IF ¿DETERIORATED¿ WAS THE EXACT VERBATIM USED THE HEALTHCARE PROVIDER (HCP) USED, BUT IT WAS ¿SOMETHING LIKE THAT.¿ THE PATIENT THOUGHT THE LEADS WERE PLACED IN A DIFFERENT SPOT. IT WAS ALSO REPORTED THAT WITH THE FIRST IMPLANTS, THE PATIENT FELT STIMULATION DOWN HER LEG TO HER TOES. PLEASE REFER TO MFG. REPORT# 3004209178-2014-12712, AS THE PATIENT HAS DUAL SYSTEMS AND THE AFOREMENTIONED REPORT IS FOR INS ON THE RIGHT SIDE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED NOTED LEAD MIGRATION NOT DETERIORATION. X-RAY REVEALED THE MIGRATION. ALL PARTS OF THE LEAD WERE EXPLANTED. THE PATIENT WAS RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402014 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention