BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2945826 · Received February 6, 2013

    Report

    Report Number
    3004209178-2013-01362
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    October 23, 2012
    Report Date
    January 16, 2013
    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
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-28, LOT# V962968, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 3037, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE HAD BEEN WORKING GREAT UP UNTIL TWO WEEKS PRIOR WHEN THE PATIENT HAD TO HAVE IT TURNED OFF BECAUSE THEY HAD BEEN SICK. IT WAS NOTED THE PATIENT COULD NOT STAND THE PULSING IN THE RECTUM. IT WAS LATER REPORTED BY THE HEALTH CARE PROFESSIONAL THAT THE CAUSE OF THE EVENT WAS CONTRIBUTED TO IMPLANTABLE NEUROSTIMULATOR (INS) RELATED PAIN. IT WAS NOTED THERE WAS INCREASING LOCAL PAIN DUE TO THE INS. IT WAS ALSO NOTED THERE WAS AN UPCOMING EXPLANT BUT NO DATE WAS NOTED. SIGNS AND SYMPTOMS INCLUDED LOCAL AND RADIATING PAIN. THERE WAS NO HOSPITALIZATION REQUIRED DUE TO THE EVENT. NO PATIENT OUTCOME WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50771 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Required Intervention