BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4143589 · Received October 6, 2014

    Report

    Report Number
    3004209178-2014-18323
    Event Type
    Injury
    Date Received
    October 6, 2014
    Report Date
    September 15, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3889-28, LOT# V175766, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WENT TO HER HEALTHCARE PROVIDER (HCP) WHEN SHE STARTED TO HAVE INCONTINENCE ISSUES. THEY WERE UNABLE TO COMMUNICATE WITH THE CLINICIAN PROGRAMMER OR PATIENT PROGRAMMER. THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) HAD FAILED AND COULD NO LONGER COMMUNICATE, SO IT HAD TO BE REPLACED. SHE DID NOT KNOW WHEN THE RETURN OF SYMPTOMS OCCURRED AT THAT TIME, BUT SHE HAD THE INS CHECKED LAST FALL. SHE NOTED THAT WITH THIS INS SHE NEVER HAD TO CHANGE A THING, UNTIL THEY REALIZED IT WOULD NO LONGER COMMUNICATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT FELT A LOW LEVEL SENSATION OF PULSE, WAS STARTING TO HAVE PROBLEMS, AND HAD THE DEVICE BATTERY CHECKED. IT SAID THE BATTERY HAD LIFE, BUT THEN ANOTHER CHECK WAS DONE AND IT SAID THAT THE INTERNAL BATTERY HAD FAILED. THE INTERNAL BATTERY DIED AND THE IMPLANT WAS ONLY FIVE YEARS OLD. THERE WAS 50 PERCENT OR GREATER SYMPTOM REDUCTION AND THE EVENT CAUSE WASN¿T DETERMINED. THERE WAS A LOSS OF THERAPEUTIC EFFECT. THE DEVICE WAS REPLACED. THE PATIENT HAD AN EXPLANT IN (B)(6) 2013 BUT WAS DOING GREAT AND RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623819 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention