BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2223868 · Received August 18, 2011

    Report

    Report Number
    3004209178-2011-06551
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    June 9, 2011
    Report Date
    July 29, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S IMPLANTABLE PULSE GENERATOR WAS REPLACED ON (B)(6) 2011 DUE TO A DEAD BATTERY. LEADS 0 AND 1 WERE ABOVE 4,000 OHMS, LEADS 2 AND 3 WERE WITHIN NORMAL LIMITS. IT WAS REPORTED THAT THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention EXPLANTED:| IMPLANTED:| LEAD: MODEL 3093, LOT# V308477