BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3233556 · Received July 18, 2013

    Report

    Report Number
    3004209178-2013-11961
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    July 22, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3116, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3093-28, LOT# V483507, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER; PATIENT PRODUCT ID 435135, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD; PRODUCT ID 435135, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS STILL HAVING CONCERNS WITH HER DEVICE OR THERAPY BUT WAS WORKING WITH HER DOCTOR AND MANUFACTURER REPRESENTATIVE. IT WAS NOTED THE PATIENT HAD AN APPOINTMENT SCHEDULED FOR (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) MIGRATED AWAY FROM THE POCKET SITE AND THE PATIENT HAD PAIN ABOUT 1 ½ INCHES TO THE RIGHT AND 1 ½ INCHES UP FROM THE INCISION. IT WAS STATED THE PATIENT COULD FEEL THE INS RIGHT UNDER THE SKIN AND THEY NOTICED THIS THE YEAR PRIOR TO REPORT. REFERENCE REGULATORY REPORT # 3004209178-2013-11960.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334092 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR