BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2840449 · Received November 20, 2012

    Report

    Report Number
    3004209178-2012-10573
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Report Date
    October 23, 2012
    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
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3093-28, LOT#: V386942, IMPLANTED: (B)(6) 2010-02-16, PRODUCT TYPE: LEAD; PRODUCT ID: 3093-28, LOT#: V386942, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD; PRODUCT ID: 3037, SERIAL#: (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID: 3037, SERIAL#: (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BURNING SENSATION 2 INCHES AWAY FROM WHERE THE DEVICE WAS LOCATED. THE PATIENT FIRST NOTICED THIS OCCURRED WHEN SHE HAD MOVED A CERTAIN WAY, 3 DAYS AGO. THE PATIENT STATED SHE THOUGHT THE LEAD HAD COME LOOSE. THE PATIENT CLAIMED TO HAVE NEVER HAD THERAPEUTIC EFFECT SINCE HER DEVICE WAS IMPLANTED. NO TRAUMA WAS KNOWN TO BE RELATED TO THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT AVAILABLE AT THE TIME OF THIS REPORT. REFER TO MANUFACTURING REPORT# 3004209178-2012-10570. A MALFUNCTION WAS ALLEGED ON TWO SYSTEMS THAT WERE IN CONCURRENT USE.

    Description of Event or Problem · 1

    FOLLOW UP FROM THE HEALTH CARE PROVIDER REPORTED THE PATIENT WOULD NOT SCHEDULE AN APPOINTMENT TO HAVE THE DEVICE CHECKED. THEY HAD SPOKEN TO THE PATIENT TWICE AND BOTH TIMES THE PATIENT DECLINED AN APPOINTMENT. REFER TO MANUFACTURER REPORT # 3004209178-2012-10570. A MALFUNCTION WAS ALLEGED ON TWO SYSTEMS THAT WERE IN CONCURRENT USE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1