BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2687613 · Received August 8, 2012

    Report

    Report Number
    3004209178-2012-06632
    Event Type
    Malfunction
    Date Received
    August 8, 2012
    Report Date
    July 25, 2012
    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
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LEAD, MODEL 3093-33, LOT# V963207, IMPLANTED: (B)(6) 2012, EXPLANTED: NA. PROGRAMMER, MODEL 3037, SERIAL# UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE PATIENT HAD THREE ACCIDENTS ONE MORNING, AND FELT PAIN WHILE USING PROGRAM 2. THE PATIENT CHANGED TO PROGRAM 1 AND PLANNED TO SEE IF SYMPTOMS IMPROVED. ADDITIONAL INFORMATION RECEIVED FROM THE HCP REPORTED THAT THE PATIENT HAD TRIPPED ON A BRICK, AND ABNORMAL IMPEDANCE MEASUREMENTS WERE SEEN IN THE LEAD. AN X-RAY ON (B)(6) SHOWED LEAD MIGRATION. THE PATIENT WAS REPROGRAMMED AGAIN ON (B)(6). IT WAS NOTED THAT THE PATIENT WAS NOT HAVING ANY FECAL INCONTINENCE. THE PATIENT WAS ABOUT TO UNDERGO HIP REPLACEMENT, AND THE HCP STATED THAT THEY WOULD NOT CHANGE THE LEAD UNTIL AFTER THAT SURGERY AND REHABILITATION. THE HCP PLANNED TO REASSESS THE PATIENT IN TWO WEEKS.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL REPORTED THAT REPROGRAMMING OF THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS PERFORMED ON JULY 17 TO THE FOLLOWING SETTINGS: BATTERY = POSITIVE, ELECTRODE #0 <(>&<)> 3 = NEGATIVE, AMPLITUDE 2.3 VOLTS. THE RESULTING PROGRAMING PROVIDE POSITIVE STIMULATION SENSATION TO THE "SADDLE ARE". ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2012 FROM THE PATIENT INDICATED THEY HAD THE HIP REPLACEMENT SURGERY ON (B)(6) 2012.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR