BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3950250 · Received July 22, 2014

    Report

    Report Number
    3004209178-2014-13355
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    June 15, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, LOT# VA00SW8, IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED AN X-RAY OF THE ABDOMEN WAS WITHIN NORMAL LIMITS. THE EVENT WAS CONSIDERED RESOLVED WITHOUT SEQUELAE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A BLADDER INFECTION. IT WAS NOTED THAT THE OUTCOME WAS ONGOING. IT WAS NOTED THAT THE PATIENT WENT TO THE ER AND RECEIVED CIPRO 500 MG. IT WAS NOTED THAT THE PATIENT ALSO RECEIVED PERCOCET. IT WAS NOTED THAT THE ETIOLOGY WAS NEW ILLNESS, INJURY. IT WAS NOTED THAT SYMPTOMS INCLUDED WEAKNESS, FATIGUE, PAIN BACK AND ABDOMEN, AND URINARY FREQUENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428763 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Required Intervention