BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4203105 · Received October 27, 2014

    Report

    Report Number
    3004209178-2014-20422
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    October 4, 2014
    Report Date
    October 7, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID; 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3889-28, LOT# V852752, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS WORKING WITH THEIR HEALTHCARE PROVIDER OR MANUFACTURER REPRESENTATIVE IN REGARD TO THEIR CONCERNS. IT WAS NOT CLEAR IF THEIR CONCERNS WERE RESOLVED OR NOT. AN APPOINTMENT DATE OF (B)(6) 2014 WAS NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ALL OF A SUDDEN IN THE LAST FEW DAYS THE PATIENT LOST CONTROL OF HER BOWEL AND SHE HAD NEVER HAD THE ISSUE BEFORE. SHE WAS IMPLANTED TO HELP WITH URINARY ISSUES; INCONTINENCE AND URINARY TRACT INFECTIONS (UTI) SPECIFICALLY. THE PATIENT STATED THAT SHE MIGHT HAVE HAD ¿LITTLE MESSES IN HER PANTIES,¿ BUT NOTHING LIKE SHE HAD IN THE AFTERNOON ON THE DAY OF THE REPORT. SHE MENTIONED THAT SHE ¿DID NOT KNOW THE DEVICE CONNECTED TO THE BOWEL UNTIL SHE WAS ON HER WAY INTO SURGERY.¿ NO INTERVENTIONS OR PATIENT OUTCOME WERE REPORTED, SO ADDITIONAL INFORMATION WAS REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682862 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR