BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 1926059 · Received November 10, 2010

    Report

    Report Number
    6000032-2010-09241
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    January 1, 2010
    Report Date
    October 25, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO, MEL REL
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED AN INCREASE IN PAIN IN HER RIGHT HIP THAT GOES DOWN HER LEG. THE PAIN STARTED "A WHILE AGO" AND HAS BEEN GETTING PROGRESSIVELY WORSE. SHE TURNED OFF HER DEVICE AND "IT SEEMS TO GET A LITTLE BETTER." THE PT THOUGHT THE DEVICE HAD "MOVED IN HER BODY." ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MDT PUERTO RICO OPERATIONS CO, MEL REL 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR IMPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 3031, LOT# NBW005712P| LEAD: MODEL 3966, LOT# LA0700| EXTENSION: MODEL 3095, LOT# NAH009248N