BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3630235 · Received February 17, 2014

    Report

    Report Number
    3004209178-2014-03060
    Event Type
    Injury
    Date Received
    February 17, 2014
    Report Date
    December 10, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. PRODUCT ID 3889-28, LOT# V517592, IMPLANTED: 2010-(B)(6). PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED HAD A URINARY TRACT INFECTION (UTI) WITH HEMATURIA THAT RESULTED IN A PROLONG IN-PATIENT HOSPITALIZATION. THE ETIOLOGY OF THESE ISSUES WAS NOTED AS A WORSENING/EXACERBATION OF A PRE-EXISTING CONDITION. THE PATIENT WAS TREATED WITH PIPERACILLIN-TAZO (4.5 GM Q 8HRS IV) AND VANCOYMCIN (1500 MG Q 12HRS IV). THE OUTCOME OF THE EVENT, AS OF (B)(6) 2012, WAS REPORTED AS RESOLVED WITHOUT SEQUELAE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100394 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Hospitalization| R