BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2716380 · Received August 28, 2012

    Report

    Report Number
    3004209178-2012-07437
    Event Type
    Injury
    Date Received
    August 28, 2012
    Report Date
    July 30, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE PULSE GENERATOR (IPG) FOUND NO ANOMALY. ANALYSIS OF THE LEAD FOUND A CUT THROUGH, PRODUCT SEGMENTED, IN THE LEAD BODY BUT NO SIGNIFICANT ANOMALY.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, LOT# V062112, SERIAL#, IMPLANTED: 2007 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD; PRODUCT ID 3037, LOT#, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), EXPLANTED: PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN ON THE LEFT SIDE WHICH WENT AWAY AFTER TURNING THE DEVICE OFF. THE LEAD AND IMPLANTABLE NEUROSTIMULATOR (INS) WERE LOCATED ON THE RIGHT SIDE. THE INS AND LEAD WERE EXPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention