BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 4210919 · Received October 29, 2014

    Report

    Report Number
    3004209178-2014-20620
    Event Type
    Injury
    Date Received
    October 29, 2014
    Report Date
    October 8, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3095-10, SERIAL # (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE EXTENSION; PRODUCT ID 3031A, SERIAL # (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3093-28, LOT # J0428300V, IMPLANTED: (B)(6) 2004, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DID NOT HAVE CONCERNS WITH THEIR DEVICE OR THERAPY AND RECEIVED ASSISTANCE FROM THEIR HEALTH CARE PROVIDER (HCP) OR MANUFACTURER REPRESENTATIVE AND THEIR CONCERNS WERE RESOLVED. THE PATIENT GOT A NEW BATTERY AND UPDATE AND HAD AN APPOINTMENT ON (B)(6) 2014. THE PATIENT WOULD HAVE ANOTHER APPOINTMENT IN 3 TO 4 WEEKS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS A 50 PERCENT OR GREATER SYMPTOM REDUCTION AFTER IMPLANTING THE NEW BATTERY. THE CAUSE OF THE EVENT WAS DETERMINED, IT WAS NOT DEVICE RELATED, AND REPROGRAMMING WAS NEEDED. THE OLD BATTERY WAS DEAD AND IT HAD LASTED GREATER THAN 10 YEARS AND THE BATTERY DEPLETION WAS NORMAL. THE SYMPTOMS RETURNED WHEN THE OLD BATTERY DIED AND HAD A LOSS OF STIMULATION, BUT THIS WAS YEARS AFTER THE EXPECTED LENGTH OF OLD BATTERY LIFE AS IT WAS PLACED PRIOR TO 2005. THE PATIENT WAS REPROGRAMMED BUT THEY HAD FORGOTTEN THEIR PATIENT PROGRAMMER ON 2 POST-OPERATIVE VISITS SO THE NEW PROGRAMS HAD NOT BEEN SAVED ON (B)(6) 2014. THE NEW DEVICE WAS NOT EXPLANTED AND THE OLD DEVICE WAS EXPLANTED AND THERE WAS NO ADVERSE EVENT WITH THE NEW DEVICE. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. THE PATIENT WAS IMPLANTED FOR MUSCLE SPASMS AND PAIN AND THE PATIENT HAD NOTICED A RETURNED OF SPASMS. THE PATIENT HAD TRIED INCREASING STIMULATION AND VERIFIED THAT THE THERAPY SHOWED ON AND THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY GREEN LIGHT WAS ON. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THE EVENT. THE SYMPTOMS HAD A SUDDEN ONSET, WERE GETTING WORSE, AND WERE HAPPENING ABOUT EVERY DAY. THE PATIENT DID NOT HAVE A CURRENT HEALTH CARE PROVIDER (HCP). NO OUTCOME OR INTERVENTIONS WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693314 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention