BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3140909 · Received June 3, 2013

    Report

    Report Number
    3004209178-2013-08494
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    May 15, 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
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID: 3093-28, LOT# VA0540D, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. T(B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE X-RAYS DETERMINED THAT THE PATIENT¿S LEAD HAD MOVED OUT OF THE S3 FORAMEN AND WAS THEREFORE NOT DELIVERING THERAPY. THE PATIENT WAS GIVEN THE OPTION TO HAVE A REPLACEMENT, HAVE THE SYSTEM REMOVED, OR LOSE WEIGHT BEFORE PROCEEDING. IT WAS REPORTED THAT THE HCP WAS AWAITING THE PATIENT DECISION.

    Description of Event or Problem · 1

    INFORMATION REVIEWED INDICATED THAT PATIENT EXPERIENCED RETURN OF INCONTINENCE AND LOST URINARY RELIEF. IT WAS ALSO INDICATED THAT IT WAS NOT WORKING FOR PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT LOST THERAPEUTIC RELIEF AND STIMULATION SENSATION A ¿COUPLE OF WEEKS AGO.¿ STIMULATION WAS SET AT 8.4V ON PROGRAM 3. THE PATIENT CHANGED PROGRAMS TO 2 AND 1. HOWEVER, IT WAS INDICATED THE PATIENT WOULD FEEL PAIN IN THEIR LOWER BACK ¿AS SOON AS¿ THEY FELT STIMULATION. PATIENT THEN WENT BACK TO PROGRAM 3. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THE COMPLAINT. IT WAS LATER REPORTED THAT THE PATIENT HAD NO STIMULATION SENSATION AFTER REPROGRAMMING. THE MANUFACTURER REPRESENTATIVE INCREASED THE PULSE WIDTH AND RATE WITHOUT SUCCESS. STIMULATION WAS INCREASED TO 8.4V AND CYCLING WAS TURNED OFF, BUT THIS DID NOT RESOLVE THE LACK OF STIMULATION. THERE WERE LOWER THAN EXPECTED IMPEDANCES: C/0 WAS AT 242 OHMS, C/1 WAS AT 250 OHMS, 0/1 WAS BELOW 50 OHMS, AND 2/3 WAS AT 166 OHMS. IT WAS LATER REPORTED THAT X-RAYS WERE PERFORMED AND THEY WERE AWAITING THE RESULTS TO DETERMINE THE NEXT STEPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244328 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR