BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4182182 · Received October 17, 2014

    Report

    Report Number
    3004209178-2014-19933
    Event Type
    Injury
    Date Received
    October 17, 2014
    Report Date
    October 9, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT# V263727, IMPLANTED: 2009 (B)(6), EXPLANTED: 2011 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED SHOCKING OR JOLTING SENSATION FOLLOWING AN IMPLANT WHICH WAS SINCE 2009 AND 2011. THE 2009 IMPLANT WAS TAKEN OUT 6 MONTHS AFTER IMPLANT. THE PATIENT WAS NOT SURE WHY THEY TOOK THIS OUT. THE PATIENT LATER NOTED THAT THE FIRST ONE CAME OUT ON ITS OWN AND STOPPED WORKING. THE PATIENT NOTED AS IT DOESN¿T WORK, SHOCKS THE BLADDER, NOT HELPING AND HURTS WHEN SHOCKING BLADDER. THE PATIENT REPORTS BEFORE FIRST IMPLANT WAS PLACED THE HEALTHCARE PROVIDER ACCIDENTLY HIT BLADDER WITH NEEDLE. SINCE THAT TIME IN 2009 THE PATIENT HAVE HAD NOTHING BUT MORE PROBLEMS. THIS WAS BEFORE AND THAT¿S WHY SHE HAD IMPLANT PLACED. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT AVAILABLE AT THE TIME OF REPORT. IF ADDITIONAL INFORMATION RECEIVED, SUPPLEMENTAL WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662091 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Required Intervention