BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3613526 · Received February 7, 2014

    Report

    Report Number
    3004209178-2014-01659
    Event Type
    Injury
    Date Received
    February 7, 2014
    Date of Event
    March 28, 2007
    Report Date
    January 16, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3093-28, LOT# V021253, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A FALL SHORTLY AFTER RECEIVING THE FIRST DEVICE AND SHE FELT LIKE SOMETHING BROKE BUT IT TOOK AWHILE TO CONVINCE HER HCP (HEALTHCARE PROVIDER). WHEN DEVICE WAS REPLACED (2010), THE MD SAID IT WASN'T BROKEN BUT THE SURROUNDING TISSUE WAS BRUISED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED NOTED THAT THE CAUSE OF THE EVENT WAS UNKNOWN. NO INJURY WAS NOTED. THE PATIENT HAD NOT REPORTED ANY PROBLEMS TO THIS REPORTER SINCE (B)(6) 2013. THIS REPORTER DID NOT KNOW THAT SHE HAD A FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79244 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention