BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3829424 · Received May 23, 2014

    Report

    Report Number
    3004209178-2014-09542
    Event Type
    Injury
    Date Received
    May 23, 2014
    Report Date
    May 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
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT FOR FOLLOW-UP WAS COMPLETED. THE IPG REMAINS IMPLANTED. THE EVENT DID NOT ALLEGE A POTENTIAL MANUFACTURING ISSUE; THEREFORE, A DHR REVIEW WAS NOT REQUIRED FOR THE IPG. THE EVENT WAS REVIEWED FOR EXISTING INVESTIGATIONS AND NONE APPLIED. THE EVENT WAS REVIEWED FOR KNOWN INHERENT RISKS LISTED IN PRODUCT LABELING AND EVENT APPLIES TO KNOWN EVENT TREND PAIN <(>&<)> DISCOMFORT, ADVERSE CHANGE IN VOIDING FUNCTION - BLADDER BECAUSE THE PT REPORTED PAIN AND SORENESS IN THEIR BACK AND THAT THE DEVICE WAS NOT HELPING THEM EMPTY THEIR BLADDER. REVIEWED FOR ESCALATION TO NCET AND ESCALATION WAS NOT REQUIRED. EVENT IS INCLUDED IN MONITORING FOR KNOWN INHERENT RISKS AS DISCLOSED IN PRODUCT LABELING. THE INVESTIGATION OF THE IPG IS INCONCLUSIVE BECAUSE THE CAUSE AND RESOLUTION OF THE EVENT ARE UNKNOWN. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT# V132957,IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S DEVICE WAS NOT HELPING THEM EMPTY THEIR BLADDER. IT WAS NOTED THE DEVICE WAS NOT WORKING CORRECTLY. IT WAS REPORTED THE PATIENT HAD PAIN IN THEIR BACK AND TURNING STIMULATION DOWN HELPED WITH THE PAIN. IT WAS NOTED THE PATIENT¿S WHOLE BACK WAS SORE. ADDITIONAL INFORMATION RECEIVED REPORTED A URINARY TRACT INFECTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308394 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Required Intervention