BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 7046993 · Received November 20, 2017

    Report

    Report Number
    3004209178-2017-24109
    Event Type
    Injury
    Date Received
    November 20, 2017
    Date of Event
    October 27, 2017
    Report Date
    December 28, 2017
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    UDI-DI
    00613994287724
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID (B)(4) LOT# V223177 SERIAL# IMPLANTED: (B)(6) 2009 EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID (B)(4) LOT# V223177 SERIAL# IMPLANTED: (B)(6) 2009 EXPLANTED: PRODUCT TYPE LEAD: PREVIOUSLY REPORTED CODES APPLIED TO THE INS, CODES REPORTED TODAY APPLY TO THE LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WITH AN IMPLANTED NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL /PELVIC FLOOR THERAPY. IT WAS REPORTED BY A FAMILY MEMBER THAT THE PATIENT GOT A NEW BATTERY AND LEAD YESTERDAY BECAUSE THE LEADS WERE JACKED UP FROM FALLING SO MANY TIMES AND THE BATTERY WAS DEAD. THE PATIENT¿S INS HAD BEEN SHUT OFF IN 2011 BECAUSE OF ANOTHER SURGERY AND THEY NEVER PUT IT BACK ON AND 2-3 WEEKS AGO FOUND THE BATTERY WAS DEAD. THEY NOTICED THE LEAD(S) WERE ¿JACKED UP¿ DURING THE NEW IMPLANT SURGERY (B)(6) 2017. THE TIMEFRAME OF THE PATIENT¿S FALLS WAS NOT REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED OR ARE ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824180 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058 00613994287724

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention