BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4903494 · Received July 9, 2015

    Report

    Report Number
    3004209178-2015-13094
    Event Type
    Injury
    Date Received
    July 9, 2015
    Report Date
    June 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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3 093-28, LOT# V735309, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. THE THERAPY ¿WAS NOT DOING WHAT IT SHOULD BE DOING FOR THE PATIENT.¿ IT WAS NOT CONTROLLING HER SYMPTOMS AND SHE WAS NOT EMPTYING HER BLADDER. THE PATIENT WAS HAVING TO CATHETERIZE MORE OFTEN AND HAD CATHED FOR THE LAST TWO DAYS ¿400-500 CC OF FLUID.¿ THE PATIENT ALSO HAD ACUTE PAIN IN THE HIP, ESPECIALLY WHEN THE WEATHER CHANGED. THE PATIENT MENTIONED THAT SHE HAD ARTHRITIS IN THE NECK AND HIP. THE PATIENT TRIED INCREASING STIMULATION THE DAY PRIOR TO THE REPORT AND WAS GOING TO TRY TO INCREASE IT AGAIN. THE PATIENT HAD AN APPOINTMENT SCHEDULED TO SEE HER HEALTH CARE PROVIDER (HCP) IN (B)(6) 2013. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP HAS BEEN CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447005 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention