BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2935439 · Received January 30, 2013

    Report

    Report Number
    3004209178-2013-01120
    Event Type
    Injury
    Date Received
    January 30, 2013
    Report Date
    January 11, 2013
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3093-28 LOT# V382104, IMPLANTED: 2010 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT LOST THERAPEUTIC EFFECT ABOUT A YEAR PRIOR TO THE REPORT. A MANUFACTURER'S REPRESENTATIVE MET WITH THE PATIENT EARLIER THAT MONTH AND COULD NOT ESTABLISH COMMUNICATION WITH THE IMPLANTABLE NEUROSTIMULATOR (INS). WHEN THE PATIENT'S POCKET SITE WAS OPENED UP DURING A REVISION SURGERY, THE LEAD HAD MIGRATED AND WAS "TWISTED AROUND THE INS". THE REPORTER STATED THAT THE LEAD WAS HOWEVER STILL INTACT AND NOT FRACTURED. THE SURGEON DID A FULL EXPLANT AND CLOSED THE POCKET. PATIENT OUTCOME WAS NOT PROVIDED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40952 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention