BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3203409 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-11239
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    November 27, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-28, LOT# V641092, IMPLANTED: (B)(6) 2011. PRODUCT TYPE: LEAD: PRODUCT ID 3037, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD A WORSENING OR EXACERBATION OF A PREEXISTING CONDITION OF INTERSTITIAL CYSTITIS. INTERVENTION INCLUDED CYSTOSCOPY; FOLLOW-UP EVALUATION OF BLADDER; TYLOX, URIBEL, CIPRO ON (B)(6) 2011; (B)(6) 2012 LORTAB 7.5; BLADDER HYDRODISTENTION; TRANSURETHRAL CAUTERIZATION OF TRIGONE ON (B)(6) 2013. THE PATIENT OUTCOME WAS NOTED AS ONGOING EVENT. ADDITIONAL INFORMATION RECEIVED UPDATED THE PATIENT INTERVENTION TO INCLUDE (B)(6) 2013 TYLOX, PYRIDIUM. IT WAS NOTED THAT THE PATIENT HAD BLADDER AND BACK PAIN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT RESOLVED WITHOUT SEQUELAE ON (B)(6) 2013.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION CHANGED THE OUTCOME FROM RESOLVED WITHOUT SEQUELAE TO AN ONGOING EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE EVENT HAD RESOLVED WITHOUT SEQUELAE ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302074 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00033 YR