BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 4665733 · Received April 7, 2015

    Report

    Report Number
    3004209178-2015-06114
    Event Type
    Injury
    Date Received
    April 7, 2015
    Report Date
    March 16, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3095-10, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3889-28, LOT# V192542, IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD REPROGRAMMING ON 2009 (B)(6), ALL FOUR PROGRAMS WERE CHANGED, AND THE IMPEDANCES AND BATTERY LIFE WERE CHECKED. IMPEDANCES WERE WITHIN NORMAL LIMITS. THERE WAS NO IMPROVEMENT IN SYMPTOMS AND NO INJURY TO THE PATIENT. THE PATIENT HAD ONLY COME IN FOR REPROGRAMMING ONCE AND THE PHYSICIAN ORDERED BOTOX AND BIOFEEDBACK, BUT THE PATIENT HADN¿T WANTED TO SCHEDULE THIS. THE CAUSE OF THE EVENT WAS UNKNOWN. THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT, THERAPY ONLY HELPED FOR A BRIEF TIME, AND IT HADN¿T HELPED SINCE. IN (B)(6) 2012, THE PATIENT THOUGHT HER IMPLANT WAS ON AND SHE DIDN¿T RECALL THE LAST TIME SHE HAD A REPROGRAMMING SESSION. THE PATIENT HAD HAD A HIP REPLACEMENT AND RECEIVED BOTOX TREATMENT, BUT IT DIDN¿T HELP HER URINARY INCONTINENCE ISSUES. OVER TWO YEARS LATER, IT WAS REPORTED THAT THERE WERE TELEMETRY ISSUES AND A CLINICIAN PROGRAMMER WAS UNABLE TO GET ANY TELEMETRY WITH THE IMPLANTABLE NEUROSTIMULATOR (INS) OR COMMUNICATE WITH THE INS FOR INTERROGATION. THE CLINIC TRIED IN THE OFFICE AND ALSO COULDN¿T GET THE INS TO COMMUNICATE. THE INS WAS EASILY FELT BELOW THE SKIN AND THE PATIENT THOUGHT SHE WAS STILL FEELING STIMULATION, BUT WAS WEARING THREE DIAPERS AND HAD A RETURN OF SYMPTOMS. IT WAS UNKNOWN WHEN THE RETURN OF SYMPTOMS STARTED. A MANUFACTURER REPRESENTATIVE HADN¿T HEARD OF ANY CONCERNS ABOUT THE LONGEVITY OF THE INS, BUT THOUGHT THE DEVICE USUALLY LASTED TEN YEARS AND THE PATIENT HAD HAD THE INS FOR ONLY SIX YEARS. THE INS WAS CHANGED OUT ON 2015 (B)(6). AFTER DEVICE REPLACEMENT AND PROGRAMMING, THE PATIENT WAS FEELING STIMULATION VAGINALLY AT 1 AMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228866 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention