BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 4274149 · Received November 24, 2014

    Report

    Report Number
    3004209178-2014-22114
    Event Type
    Injury
    Date Received
    November 24, 2014
    Report Date
    October 30, 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
    SD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3095-10, SERIAL# (B)(4). IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION. PRODUCT ID 3889-41, LOT# V007590, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD. PRODUCT ID 3889-41, LOT# V132494, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD. PRODUCT ID 3031A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REPROGRAMMING WAS ATTEMPTED SEVERAL TIMES BY THE HEALTHCARE PROVIDER BUT THE DEVICE WAS NOT EFFECTIVE. THE PATIENT EXPERIENCED SOME DISCOMFORT AT THE POCKET SITE. THE DEVICE WAS REMOVED AS IT WAS NOT FUNCTIONING AND THE PATIENT HAS A HISTORY WITH MS AND WOULD NEED FUTURE MRIS. IT WAS ALSO MENTIONED THAT PATIENT HAD SEVERAL REVISIONS AND NEVER HAD IMPROVEMENT OF THE FUNCTION. ADDITIONAL INFORMATION RECEIVED A WEEK LATER INDICATED THAT PATIENT WAS NOT GETTING 50% OR GREATER SYMPTOM REDUCTION. THE CAUSE OF THE EVENT WAS NOT DETERMINED AND WAS REPORTED AS UNKNOWN IF DEVICE RELATED. IT WAS ALSO NOTED AS UNKNOWN IF REPROGRAMMING WAS NEEDED. THE PATIENT EXPERIENCED LOSS OF THERAPEUTIC EFFECT AND WAS REPORTED AS UNKNOWN IF SUDDEN OR GRADUAL. IT ALSO REPORTED AS UNKNOWN IF PATIENT HAD LOSS OF STIMULATION. THE PATIENT NOT RECOVERED SYMPTOM/ISSUE ONGOING. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. A FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760787 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Required Intervention