BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3257361 · Received July 31, 2013

    Report

    Report Number
    3004209178-2013-12583
    Event Type
    Injury
    Date Received
    July 31, 2013
    Report Date
    July 25, 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
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3093-33, LOT# V042644, IMPLANTED: (B)(6) 2007. PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS NOT FELT STIMULATION FOR THE PAST 3-4 DAYS. IT WAS NOTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS IMPLANTED IN 2007 AND MAY NEED TO BE CHECKED. IT WAS LATER REPORTED THAT THE PATIENT DID NOT HAVE CONCERNS WITH HER DEVICE OR THERAPY. THE PATIENT RECEIVED ASSISTANCE ON (B)(6) 2013 AND HER CONCERNS WERE RESOLVED. IT WAS NOTED THAT THE PATIENT HAD AN APPOINTMENT SCHEDULED FOR (B)(6) 2013. ADDITIONAL INFORMATION RECEIVED FROM THE HEALTH CARE PROVIDER (HCP) REPORTED THAT THE CAUSE OF THE EVENT WAS "POSSIBLE FROM A FALL ON (B)(6) 2012". THERE WERE IMPEDANCES OF GREATER THAN 4,000 OHMS REPORTED. IT WAS STATED THAT THERE WAS A REPLACEMENT OF THE IMPLANTABLE NEUROSTIMULATOR (INS) ON (B)(6) 2013. IT WAS REPORTED THAT THE PATIENT RECOVERED WITHOUT SEQUELA. IT WAS STATED THAT THE INS WAS "EXHAUSTED". IT WAS NOTED THAT THE PLAN WAS TO REMOVE THE INS AND PLACE A NEW ONE AT A NEW LOCATION BECAUSE THE PATIENT WAS EXPERIENCING "LOCAL SITE PAIN". THE EXISTING LEAD WAS RE-USED WITH A NEW INS. IMPEDANCES WERE TESTED INTRA-OPERATIVELY WITH "NORMAL FINDINGS AND NORMAL IMPEDANCES". REFER TO MANUFACTURER REPORT #3004209178-2013-07727 FOR INFORMATION ON THE FALL THAT HAPPENED ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357658 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Required Intervention