BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 2230444 · Received August 15, 2011

    Report

    Report Number
    3004209178-2011-06351
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    January 1, 2009
    Report Date
    July 20, 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
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE STIMULATION WAS TURNED ON, THE PT EXPERIENCED SPASMS IN HER WRISTS, ANKLES, AND KNEES. THE SYMPTOMS DID NOT OCCUR WHEN THE DEVICE WAS TURNED OFF. THE PT CONSULTED MANY PHYSICIANS REGARDING THE ISSUE, AND WAS INSTRUCTED BY A PHYSICIAN TO TURN STIMULATION OFF. THE SPASMS THEN STOPPED. THE DEVICE HAD BEEN OFF FOR TWO MONTHS. THE SYMPTOMS HAD BEEN OCCURRING FOR TWO YEARS AND BEGAN FOLLOWING A FALL. THE PT WAS "ALWAYS FALLING" AND SHE FELT AS IF HER NEUROSTIMULATOR WAS "CRACKED". THE PT HAD A URINARY TRACT INFECTION AND WAS TAKING ANTIBIOTICS. IT WAS LATER REPORTED THAT THE NEUROSTIMULATOR WAS REPLACED THE FIRST WEEK OF (B)(6) 2011. ADDITIONAL INFO HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention IMPLANTED:| IMPLANTED:| LEAD: MODEL 3093, LOT# J0230870V| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 3095, LOT# NAH005228V| PROGRAMMER: MODEL 3031A, LOT# NGM005859P