BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4130493 · Received September 30, 2014

    Report

    Report Number
    3004209178-2014-18026
    Event Type
    Injury
    Date Received
    September 30, 2014
    Report Date
    September 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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT# VA0FQD2, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED NEVER HAD THERAPEUTIC EFFECT AND HAD MET WITH THE MANUFACTURER REPRESENTATIVE COUPLE OF TIMES BUT NOTHING HAS IMPROVED HIS RESULTS. THE PATIENT MOST RECENTLY SAW THE MANUFACTURER REPRESENTATIVE A COUPLE MONTHS AGO. THE PATIENT INDICATED THAT IF HE "CRANK TOO HIGH" HIS "BUTT" WOULD START TO HURT AND HE HAS TO DROP THE SETTING "BACK ONE". THE PATIENT REPORTED THE THERAPY WAS NOT EFFECTIVE ON ANY SETTING, WHETHER HE CRANKS IT TOO HIGH OR SETS IT AT A COMFORTABLE SETTING. THE PATIENT HAD RESORTED TO WEARING DEPENDS AND STATED IF HE DRIVES ANYWHERE HE KNOWS WHERE ALL THE RESTROOMS ARE TO STOP AT. IT WAS INDICATED THAT THE SYMPTOM OCCURRED FOLLOWING THE IMPLANT AND STATED THE TRIAL WORKED WELL. THE PATIENT STATED HE HAD NEVER GOTTEN ANY REAL SATISFACTION ONCE THE NEUROSTIMULATOR (INS) WAS IMPLANTED. IT WAS INDICATED THAT THE HEALTH CARE PROVIDER ASSESS THE LEADS AND EVERYTHING LOOKED FINE BUT COULD NOT REMEMBER THE DATE WHEN THE LEAD WAS ASSESS. THE PATIENT NEXT APPOINTMENT IS SCHEDULED IN 3 WEEKS. IT WAS REPORTED FOUR DAYS LATER THAT PATIENT HAD 50% OR GREATER SYMPTOM REDUCTION .THE CAUSE OF THE EVENT WAS REPORTED AS UNKNOWN. IT WAS ALSO REPORTED AS UNKNOWN IF DEVICE RELATED. IT WAS INDICATED THAT THE DEVICE WAS REMOVED. IT NOTED AS UNKNOWN IF PATIENT WAS RECEIVING EFFECTIVE THERAPY. 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.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT STILL HAD CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT WAS WORKING WITH THEIR HEALTH CARE PROVIDER (HCP) OR MANUFACTURER REPRESENTATIVE. NO OUTCOME WAS 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
    608600 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Required Intervention