BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3132465 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-08223
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    May 7, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3093-28, LOT# V103838, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT¿S URINARY TRACT INFECTION WAS TREATED AND PATIENT HAD DONE "WELL."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A BLADDER INFECTION THE DAY AFTER THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS IMPLANTED. THE PATIENT¿S HEALTHCARE PROVIDER (HCP) REPORTEDLY CHECKED THE PATIENT¿S BLADDER AND SAID IT WAS EMPTYING ¿BEAUTIFULLY¿. THE PATIENT WAS PUT ON ANTIBIOTICS. THE REPORTER INDICATED THAT THE PATIENT WAS SCHEDULED FOR A FOLLOW-UP APPOINTMENT WITH HIS HCP THE FOLLOWING WEEK. **OMITTED INFORMATION PERTAINING TO RELATED PE (B)(4) NO STIMULATION**

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235909 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention