BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3122635 · Received May 21, 2013

    Report

    Report Number
    3004209178-2013-07987
    Event Type
    Injury
    Date Received
    May 21, 2013
    Report Date
    May 1, 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3058, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2013, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3093-28, LOT# V054682, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3093-28, LOT# V017147, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT HE WAS ON LOW-DOSE ANTIBIOTICS THAT HE TAKES EACH DAY DUE TO RECURRING INFECTIONS IN THE PAST. THE PATIENT DISCUSSED AN INFECTION THAT OCCURRED IN (B)(6) 2010 THAT MADE HIM VERY SICK. THE PATIENT BELIEVED HEHAD BRAIN DAMAGE FROM THE INFECTION. THE PATIENT WAS IN THE PARKING LOT AND HIT A CAR, THEN DROVE INTO A POLE BECAUSE HE SAID HE ¿LOST HIS COMMON SENSE¿ DUE TO THE INFECTION. THE PATIENT STATED THAT HE THEN GOT THE PROPER ANTIBIOTICS AND BEGAN TO FEEL BETTER. THE PATIENT ALSO REPORTED THAT HE WENT INTO HEAD-ON TRAFFIC ON A SIX LANE HIGHWAY DUE TO THE INFECTION CAUSING HIM ¿TO LOSE HIS BRAINSAND COMMON SENSE.¿ ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. SEE ALSO MANUFACTURER¿S REPORT # 3004209178-2013-07986.

    Description of Event or Problem · 1

    FOLLOW-UP WITH THE PATIENT¿S HEALTHCARE PROVIDER INDICATED THAT THE PATIENT FREQUENTLY GOT URINARY TRACT INFECTIONS. THE PATIENT SELF-CATHETERIZED HIMSELF ¿ALONG WITH OBVIOUSLY HAVING THE DEVICE¿. THE FOLLOWING DAY, IT WAS REPORTED THAT THE REASON THE PATIENT WAS GETTING THE FREQUENT UTIS WAS IN REGARDS TO THE RETENTION AS FAR AS THE PATIENT SELF-CATHETERIZING. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS FRIGHTENED WHEN THEY LOST THEIR COMMON SENSE. IT WAS NOTED THAT IT HURT THE PATIENT TO GET UP AND IT HURT TO SIT DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224363 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention