BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 2862867 · Received December 10, 2012

    Report

    Report Number
    3004209178-2012-11295
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    November 9, 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
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3095-10 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 3093-28 LOT# V138325, IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3031A LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT NEVER HAD THERAPEUTIC EFFECT. IT WAS NOTED, THE IMPLANT HAD NOT DONE ANYTHING FOR THE PATIENT AND THAT THE IMPLANT HAD NEVER WORKED. IT WAS NOTED, THE PATIENT HAD THE ENTIRE SYSTEM REMOVED BECAUSE, THEY HAD MULTIPLE SCLEROSIS AND COULD NOT HAVE AN MRI, THE PATIENT HAD NOT KNOWN THIS PRIOR TO IMPLANT. IT WAS ALSO NOTED, IT TOOK TWO YEARS FOR THE PATIENT TO FIND A HEALTH CARE PROVIDER TO REMOVE THE IMPLANT AND THE PATIENT HAD NOT BEEN HAPPY ABOUT IT. THE HEALTH CARE PROVIDER DID NOT WANT TO REMOVE THE IMPLANT. IT WAS ALSO NOTED, THE PATIENT'S STIMULATION HAD BEEN TURNING OFF. PATIENT HAD BEEN TURNED OFF FOR TWO YEARS. PATIENT HAD BEEN GETTING "SHOT" ONCE A WEEK AND HAD BEEN TAKING PILLS FOR MS BUT DID NOT KNOW IF IT HAD BEEN HELPING BECAUSE, THEY COULD NOT GET AN MRI. PATIENT WOULD HAVE BOTOX INJECTED IN TO THEIR BLADDER TO SEE IF THAT WOULD HELP. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED CLARIFIED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) WAS REMOVED DUE TO "MALFUNCTION (SUBJECTIVE)" IN ADDITIONAL TO THE NEED FOR THE MRI DUE TO THE PATIENT'S MULTIPLE SCLEROSIS. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention