BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2855028 · Received December 3, 2012

    Report

    Report Number
    3004209178-2012-11091
    Event Type
    Injury
    Date Received
    December 3, 2012
    Report Date
    November 7, 2012
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT# V380838, IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A FALL AND AN EXPLANT. IT WAS STATED THAT THE PATIENT'S PRIOR IMPLANTABLE NEUROSTIMULATOR (INS) HAD TO BE REPLACED AFTER THE PATIENT FELL IN (B)(6) 2011. THE PATIENT REPORTEDLY BROKE HER HIP WHEN SHE FELL AND HAD TWO SURGERIES TO FIX IT. IT WAS NOTED THAT AFTER THE HIP SURGERIES, "EVERYTHING" WAS REPLACED "INCLUDING THE LEADS." IT WAS FURTHER NOTED THAT THE INS REPLACEMENT WAS AN "EMERGENCY." IT WAS LATER REPORTED THAT THE PATIENT WAS REPROGRAMMED. THE PATIENT STATUS WAS UNKNOWN. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention