BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3240888 · Received July 22, 2013

    Report

    Report Number
    3004209178-2013-12083
    Event Type
    Injury
    Date Received
    July 22, 2013
    Report Date
    September 22, 2013
    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID: 3 093-28 LOT# V779499, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED ON (B)(6)-2013 THE PATIENT HAD AN OUTPATIENT CYSTOSCOPY, HYDRO DISTENTION, TRANSURETHRAL CAUTERIZATION OF BLADDER ULCERS AND WIDE CALIBER URETHRAL DILATION. IT WAS STATED THE PATIENT RECOVERED WITHOUT SEQUELAE ON (B)(6)-2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A WORSENING OF INTERSTITIAL CYSTITIS. IT WAS NOTED THAT INTERVENTIONS INCLUDED A CYSTOSCOPY AND PERCOCET, DEMEROL 50MG AND PHENERGAN 25MG WERE PRESCRIBED ON 2013 (B)(6). IT WAS ALSO NOTED THAT THE PATIENT'S PRE-EXISTING CONDITION WORSENED OR WAS EXACERBATED. IT WAS STATED, THE PATIENT'S SIGNS AND SYMPTOMS INCLUDED SEVERE BLADDER PAIN. IT WAS FURTHER NOTED THAT THIS WAS AN ONGOING EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION CHANGED THE EVENT OUTCOME FROM RESOLVED WITHOUT SEQUELAE TO AN ONGOING EVENT. IT WAS ALSO NOTED ANOTHER CYSTOSCOPY WAS DONE FOR AN INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340926 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Required Intervention