BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 5199405 · Received November 3, 2015

    Report

    Report Number
    3004209178-2015-22151
    Event Type
    Injury
    Date Received
    November 3, 2015
    Report Date
    October 14, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT.  A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INS S/N: (B)(4) FOUND THE PROGRAMMING/ SERIAL NUMBER WAS ALTERED. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3 889-28, LOT# V022884, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM THE MANUFACTURERS' REPRESENTATIVE REPORTED THAT HE COULD NOT PROVIDE ADDITIONAL INFORMATION ON THE DEVICE RETURNED. THE DEVICE WAS REMOVED ON (B)(6) 2015.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD SOMEHOW SHIFTED AND WAS PRESSING AGAINST THE SKIN IN THE BUTTOCKS. IT WAS PAINFUL AND UNCOMFORTABLE AT THE INS SITE IN THE BUTTOCKS. THIS OCCURRED IN (B)(6) 2015. THE PATIENT WENT TO THE DOCTOR (B)(6), BUT DID NOT HAVE TIME UNTIL THE DAY OF THE REPORT TO DO SOMETHING ABOUT THE ISSUE. THE PATIENT HAD A REVISION. IT WAS NOTED THAT THE PATIENT GAVE HER PATIENT PROGRAMMER (PP) TO A MANUFACTURING REPRESENTATIVE (REP) AND SHE DID NOT GET ONE BACK. SHE WAS WONDERING IF SHE WOULD BE GETTING IT BACK OR BE GETTING A NEW ONE. THE REP LATER REPORTED THAT THE REP HAD GIVEN THE PATIENT A NEW ONE AND THE PATIENT MUST NOT HAVE REMEMBERED. SHE HAD SOME MEMORY LOSS ISSUES. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDES URINARY DYSFUNCTION/SACRAL NERVE STIM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729720 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention