BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3311917 · Received August 27, 2013

    Report

    Report Number
    3004209178-2013-15270
    Event Type
    Malfunction
    Date Received
    August 27, 2013
    Report Date
    August 2, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3 889-28 LOT# V840309, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD HAD AN UNRELATED COLON SURGERY ONE MONTH PRIOR TO THIS REPORT. THE PATIENT HAD REPORTEDLY TURNED THE DEVICE OFF DURING SURGERY AND KEPT IT OFF FOR THREE WEEKS. THE PATIENT STATED THAT WHEN THE DEVICE WAS TURNED BACK ON, THE PROGRAMS WERE GONE. THE PATIENT HAD SEEN HER HEALTH CARE PROVIDER (HCP) THE WEEK PRIOR TO THIS REPORT AND HAD ONLY HAD ONE PROGRAM. THE PATIENT STATED THAT THE ONE PROGRAM DID NOT WORK WELL FOR HER. IT WAS LATER REPORTED THAT THE PATIENT STILL HAD CONCERNS REGARDING THE DEVICE OR THERAPY BUT WAS WORKING WITH AN HCP OR MANUFACTURING REPRESENTATIVE. THE PATIENT REPORTEDLY HAD AN APPOINTMENT ON (B)(6) 2013. 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
    419382 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR