BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4251371 · Received November 14, 2014

    Report

    Report Number
    3004209178-2014-21606
    Event Type
    Injury
    Date Received
    November 14, 2014
    Report Date
    October 22, 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
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# VA0AJQH, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S IMPLANT WAS VERY PAINFUL AND IT ¿CUTS ITSELF OFF¿ AND WAS FLIPPED. THE PATIENT STATED IT WAS CAUSING AN ISSUE WITH THE MOVEMENT OF THEIR LEG. THE PATIENT HAD PAIN NEAR THEIR KIDNEY, GENERALLY IN THE IMPLANT AREA AND IT WENT DOWN BOTH LEGS, AND HURT THE PATIENT ON THE OUTER THIGHS. THE PATIENT INITIALLY SAID IT HAD BEEN A COUPLE OF MONTHS, BUT THEN LATER SAID LONGER, PERHAPS SINCE (B)(6) 2014. AN X-RAY WAS DONE ON (B)(6) 2014 TO CONFIRM A FLIPPED IMPLANT AND AGAIN ON (B)(6) 2014. THE PATIENT WAS SCHEDULED FOR DEVICE REMOVAL ON (B)(6) 2014. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737803 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Required Intervention