BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4519450 · Received February 16, 2015

    Report

    Report Number
    3004209178-2015-03074
    Event Type
    Malfunction
    Date Received
    February 16, 2015
    Report Date
    January 22, 2015
    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 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3889-41, LOT# V861350, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED PATIENT BATTERY LIFE WAS LOW AND IMAGING SHOWED INTACT LEAD. THE PATIENT WAS SET UP FOR BATTERY REPLACEMENT. IT WAS NOTED THAT PATIENT EXPERIENCED LOSS OF THERAPEUTIC EFFECT THAT HAD A GRADUAL ONSET.

    Description of Event or Problem · 1

    IT WAS PATIENT HAD CONCERNED THAT THE INTERNAL BATTERY FAILING. THE PATIENT REPORTED THAT SUDDENLY, NO MATTER WHAT SETTING SHE PUTS THE STIM ON, SHE HAD CONSTANT LEAKAGE, WAS UP ALL NIGHT LONG, AND DID NOT SEEM TO BE ANY CONTROL WHAT SO EVER. THE PATIENT REPORTED THAT IT STARTED INTERMITTENTLY ABOUT A MONTH AGO, BUT CONSTANTLY ABOUT A WEEK AGO. THE PATIENT WENT TO THE EMERGENCY ROOM (ER) AND THEY THOUGHT THAT IT WAS THE BATTERY. THE PATIENT ALSO REPORTED SHE HAD A TETHERED SPINAL CORD AND THOUGHT THAT HAD GOTTEN WORSE. THIS MAY BE CAUSING PROBLEMS AND THAT WAS WHY PATIENT WENT TO THE ER, EARLIER THIS WEEK. THE PATIENT CONFIRMED SHE WAS STILL ABLE TO COMMUNICATE WITH NEUROSTIMULATOR (INS) USING PATIENT PROGRAMMER (PP). THE PATIENT WAS UP ON THE HIGHEST SETTING POSSIBLE. THE PATIENT REPORTED NO FALL OR TRAUMA. THE PATIENT LATER REPORTED THAT THE REASON FOR HIS VISIT TO THE ER FEW DAYS AGO WAS BECAUSE OF LEAKAGE AND DUE TO PATIENT¿S SPINAL CORD. THE PATIENT STATED HER SPINAL CORD WAS RE-TETHERED AND THOUGHT HER STIMULATOR INS WAS DYING. THE PATIENT ALSO REPORTED LOSS OF THERAPEUTIC EFFECT. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. A FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111017 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Required Intervention