BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 5007154 · Received August 17, 2015

    Report

    Report Number
    3004209178-2015-16108
    Event Type
    Injury
    Date Received
    August 17, 2015
    Report Date
    July 28, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3031A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3889-28, LOT# V001759, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    THE HEALTH CARE PROFESSIONAL VIA THE MANUFACTURERS REPRESENTATIVE REPORTED LACK OF THERAPY. THERE WAS NO EFFICACY. IT WAS UNKNOWN IF ANY DIAGNOSTICS OR TROUBLESHOOTING WAS PERFORMED. REPROGRAMMING WAS DONE TO RESOLVE THE ISSUE. IT WAS ALSO UNKNOWN IF THE ISSUE RESOLVED AT THE TIME OF THE REPORT. THERE WAS A PLAN TO EXPLANT THE DEVICE ON (B)(6) 2015. THE PATIENT WAS INDICATED FOR URINARY DYSFUNCTION/ SACRAL NERVE STIMULATION. NO FURTHER INFORMATION WAS PROVIDED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541816 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Required Intervention