BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2873594 · Received December 14, 2012

    Report

    Report Number
    3004209178-2012-11824
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Report Date
    November 26, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-33, LOT # V911221, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED ACUTE PAIN AS A SYMPTOM. THE PATIENT HAD PAIN/PROBLEMS WITH HER RIGHT HIP AREA WHERE THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD BEEN IMPLANTED. IT WAS STATED THAT THE PATIENT "MIGHT HAVE PULLED SOMETHING OR AFFECTED HER SCIATIC NERVE."

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A LOSS OF THERAPEUTIC EFFECT IN EARLY OCTOBER. PATIENT HAD THEIR ACHILLES TENDON REPAIRED IN SEPTEMBER AND THEY HAD DIFFICULTY MOVING AROUND AND NOTICED THEY WERE LEAKING MORE. PATIENT FELL FAIRLY HARD ON A CONCRETE FLOOR IN SEPTEMBER ON THEIR LEFT SIDE. IT WAS NOTED THE PATIENT MAY NEED TO HAVE THEIR ROTATOR CUFF LOOKED AT. PATIENT ALSO HAD A LIGHT BURNING SENSATION AT THE IMPLANT SITE THAT WAS NOTICED 3-4 WEEKS PRIOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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