BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2102692 · Received May 19, 2011

    Report

    Report Number
    3004209178-2011-03674
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    April 1, 2011
    Report Date
    May 3, 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
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    RECEIVED INFO THE PT EXPERIENCED A LOSS OF THERAPEUTIC STIMULATION FOLLOWING USE OF A TENS UNIT IN PHYSICAL THERAPY. PT HAS NOT HAD STIMULATION FOR (B)(6). THE MANUFACTURER'S PT SERVICES WORKED WITH THE PT TO SWITCH BETWEEN PROGRAMS WITH THE PT PROGRAMMER. PT STILL COULD NOT FEEL STIMULATION IN GROUP 2 AND IT WAS AT THE MAX OF 2.1. GOING TO GROUP 1 AT 0.9 ALLOWED STIMULATION. ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS 3058 H0213649

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR PROGRAMMER: MODEL 3037, LOT# NJD076414N| IMPLANTED:| LEAD: MODEL 3889, LOT# V137025| EXPLANTED: