BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3102390 · Received May 9, 2013

    Report

    Report Number
    3004209178-2013-07423
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Report Date
    April 19, 2013
    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
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT# J0519591V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE LEAD; PRODUCT ID 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NIGHT PRIOR TO THE REPORT THE PATIENT DID NOT FEEL STIMULATION. THE PATIENT ATTEMPTED TO TURN THE STIMULATION OFF AND SAW THE INFORMATION SCREEN BUT DID NOT RECALL WHAT ICONS OR CODES APPEARED. THE PATIENT ¿FELT¿ THE STIMULATION WAS TURNING ITSELF OFF EVERY HOUR. THE PATIENT HAD NOT ¿CHANGED¿ HER STIMULATION IN MONTHS. THE PATIENT STATED THAT THE URINARY ¿WAS KINDA NOT HELPING HER¿ BUT SHE WAS HAVING ISSUES WITH ¿SPASM.¿ THE PATIENT WAS LAST SEEN ON (B)(6) 2011 AND WAS DOING WELL. AT THAT TIME HOSPITALIZATION WAS NOT REQUIRED AND THE PATIENT OUTCOME WAS NOTED AS NO INJURY. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203138 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1