BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 5007307 · Received August 17, 2015

    Report

    Report Number
    3004209178-2015-16113
    Event Type
    Injury
    Date Received
    August 17, 2015
    Report Date
    July 23, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3093-28, LOT# V926162, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT AND WAS AGGRAVATED. THE PATIENT WAS EXPERIENCING URINARY FREQUENCY. THEY WERE GOING ABOUT FIVE TIMES EVERY FIFTEEN MINUTES. FOLLOW-UP FROM THE HEALTHCARE PROVIDER (HCP) REPORTED THAT THE PATIENT DID NOT HAVE A LOSS OF THERAPEUTIC EFFECT, BUT DID HAVE A LOSS OF STIMULATION. REPROGRAMMING OCCURRED ON (B)(6) 2015. THE PATIENT HAD GREATER THAN FIFTY PERCENT SYMPTOM REDUCTION AND RECOVERED WITHOUT PERMANENT IMPAIRMENT. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2015 FROM THE PATIENT HAD ALL FOUR BOXES MARKED ON THE LETTER. SHE REPORTED BOTH THAT HER ISSUES RESOLVED AFTER RECEIVING HELP AND THAT SHE STILL HAD ISSUES AND CONCERNS, BUT HAD SOUGHT FURTHER HELP. SHE VOIDED FOUR TIMES "LEEF ON LUNCH AND IT DID NOT SEEM TO HELP HER THAT MUCH. SHE HAD AN APPOINTMENT SCHEDULED FOR (B)(6) 2015 AND "NEED SURGERY -FEMALE." IT WAS UNCLEAR IF SHE JUST THOUGHT SHE NEEDED SURGERY OR ACTUALLY HAD SURGERY SCHEDULED FOR THAT DAY. ADDITIONAL INFORMATION REPORTED ON (B)(6) 2015 INDICATED THAT THE DEVICE WAS EXPLANTED ON (B)(6) 2015. THE PATIENT WAS DIAGNOSIS WITH GASTROINTESTINAL/ PELVIC FLOOR. 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
    541254 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Required Intervention