BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 4414496 · Received January 13, 2015

    Report

    Report Number
    3004209178-2015-00638
    Event Type
    Injury
    Date Received
    January 13, 2015
    Report Date
    December 18, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3889-33, LOT# V132935, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT¿S EXPERIENCE WITH THE MANUFACTURER WAS NOT GOOD. THE PATIENT DIDN¿T KNOW WHY THEY WERE SENT THE SURVEY AND THE MANUFACTURER NEVER ANSWERED THE QUESTIONS THEY HAD. THE PATIENT WAS ALWAYS TOLD TO CONTACT THEIR PHYSICIAN AND WAS NOT PLEASED AT ALL WITH THE SERVICE THEY GOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A URINE SAMPLE TAKEN AND IT WAS DETERMINED THAT SHE HAD A URINARY TRACT INFECTION. THE PATIENT WAS GIVEN MEDICATION FOR IT ABOUT THREE DAYS PRIOR TO THE REPORT AND SHE HAD BEEN TAKING IT. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30465 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Required Intervention