BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4013056 · Received August 15, 2014

    Report

    Report Number
    3004209178-2014-15392
    Event Type
    Malfunction
    Date Received
    August 15, 2014
    Report Date
    July 18, 2014
    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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-33, LOT# V345214, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    MORE THAN A YEAR PRIOR TO THE DATE OF THIS REPORT, IT WAS STATED THE PATIENT¿S NEUROPATHY WAS AGGRAVATED WHILE STIMULATION WAS ON. THE PATIENT COULD NOT SLEEP BECAUSE THEY HAD PAIN IN THE LEG AND THEIR TOE WAS JUMPING IN THE AIR. THE SENSATION WAS PAINFUL AND AN OVERSTIMULATION SENSATION WAS NOTED. IT WAS NOTED THAT ¿STIMULATION WAS OFF, AND ON VERY MILD.¿ THE PATIENT NEEDED THE DEVICE TO TURN COMPLETELY OFF. IT WAS STATED THE PATIENT COULD NOT WALK OR GET OUT OF BED. THEY HAD NEUROPATHY FROM THEIR WAIST ALL THE WAY DOWN TO THEIR FEET, WHICH MADE IT WORSE. THE PATIENT REPORTED FEELING RESIDUAL STIMULATION AND PAIN EVEN WITH THE DEVICE TURNED OFF. THE PAIN WAS IN BOTH LEGS. IN ADDITION, THE PATIENT WAS SUPPOSED TO HAVE SURGERY TO REMOVE A MESH, BUT THEY HAD TO CANCEL BECAUSE OF THE INTERSTIM THERAPY. AS OF THE DATE OF THIS REPORT, IT WAS INDICATED THE PATIENT FELT LIKE THEY WERE BEING ¿ELECTROCUTED¿ FROM THEIR HIPS TO THEIR LEGS FOR THE LAST 3-4 DAYS. THE DEVICE HAD BEEN TURNED OFF FOR OVER A YEAR BECAUSE THEY WERE HAVING THIS TYPE OF SENSATION AND BECAUSE THEY WERE NOT GETTING URINARY RELIEF. THE IMPLANTABLE NEUROSTIMULATOR WAS REPORTEDLY ¿NOT WORKING¿ AND HAD BEEN ¿QUIET.¿ IT WAS UNKNOWN WHAT THE ¿QUIET¿ REFERRED TO. THE PATIENT HAD SURGERY ON (B)(6) 2014 TO REMOVE A MESH IN THE VAGINAL REGION. SINCE THEN, THE DEVICE HAD BEEN GIVING THE PATIENT SHOCKS ¿ON AND OFF.¿ THE PATIENT¿S PAIN WAS A ¿TEN OUT OF TEN¿ AND THE PATIENT HAD BEEN LYING IN BED. IT WAS THOUGHT THAT ¿PERHAPS¿ THE DOCTOR MIGHT HAVE TURNED STIMULATION ON AT A HIGH SETTING. IN ADDITION, THE PATIENT WAS A VERY ¿ILL¿ PERSON AND THEY CURRENTLY HAD THEIR LEGS UP IN STIRRUPS. THEY WERE IN A LOT OF PAIN AND ¿PROBABLY NOT THINKING CLEARLY.¿ NO OUTCOME WAS PROVIDED WITH THIS EVENT. FURTHER FOLLOW UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489580 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1