BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4867051 · Received June 24, 2015

    Report

    Report Number
    3004209178-2015-12187
    Event Type
    Injury
    Date Received
    June 24, 2015
    Report Date
    June 3, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 3093-28, LOT # V151540, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3058, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3093-28, LOT # V319832, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3093-28, LOT # V151540, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3093-28, LOT # V319832, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A HEAD INJURY, SWELLING, AND SUBSEQUENT SURGERY IN APRIL 2015. THE PATIENT¿S DEVICE WAS TURNED OFF AT THE TIME OF THE INJURY/SURGERY AND THE PATIENT WAS THEN USING A CATHETER. IN (B)(6) 2015, THE PATIENT HAD A LOSS OF THERAPY AND A STIMULATION ISSUE AFTER TURNING STIMULATION BACK ON AFTER INJURY/SURGERY. PROGRAMS WERE CHANGED BUT REPORTED NO STIMULATION SENSA TION. THE PATIENT FELT STIMULATION WHEN INCREASING SETTINGS, BUT LATER DID NOT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE ENTIRE DEVICES WERE INVOLVED IN THE EVENT AS THERE WAS AN INFECTION. NO TROUBLESHOOTING WAS ATTEMPTED, BUT ANTIBIOTICS WERE TAKEN. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) REPORTED THAT THE "RIGHT" SIDE IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPLACED DUE TO THE INS "NOT WORKING CORRECTLY" AS WELL AS BECOMING DISLODGED AND NOT STAYING IN PLACE. HOWEVER, UNCLEAR AS TO WHICH ACTUAL DEVICE WAS REMOVED ON (B)(6) 2015 DUE TO CONFLICTING INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409263 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Required Intervention