BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 1932074 · Received November 30, 2010

    Report

    Report Number
    3004209178-2010-10014
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    October 1, 2010
    Report Date
    November 22, 2010
    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
    TX, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFO RECEIVED INDICATED THAT THE NEUROSTIMULATOR ON THE PT'S RIGHT SIDE HAD THE POWER-ON-RESET (POR) CONDITION. THE DEVICE ON THE LEFT SIDE WAS NOTED AS WORKING FINE. THERE WAS NO ACCIDENT OR INCIDENT SPECIFICALLY RELATED TO THIS EVENT. THE PT WAS SEEN ON (B)(6), 2010 AND THE DEVICE ON THE RIGHT SIDE WAS INTERROGATED AND WAS AT POR STATUS. THE POR WAS CLEARED AND THE DEVICE WAS REPROGRAMMED TO 2 PROGRAMS (PROGRAM 1: 4.9 VOLTS, 210 PW, 14 HZM, C+, 1-; PROGRAM 2: 3.8 VOLTS 210 PW, 14 HZM, C+, 0, 1+). THE PT WENT HOME AND DID NOT TOUCH THE PT PROGRAMMER UNTIL EARLY LAST WEEK WHEN HE HAD A RETURN OF SYMPTOMS. WHEN HE TRIED TO USE THE PROGRAMMER, HE GOT NO RESPONSE. THE COMPANY REP REPORTED THAT THE DEVICE BATTERY STATUS WAS OKAY AND ESTIMATED TO LAST ONE YEAR. IT WAS NOTED THAT THE PT HAD A BONE SCAN AND EKG PRIOR TO THE POR MESSAGE BEING SEEN. THE PT WAS REPORTED IN FAIR CONDITION. ADDITIONAL INFO WAS REQUESTED.

    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 70 YR Male EXPLANTED:| IMPLANTED:| LEAD: MODEL 3093, LOT# V380835.| PROGRAMMER: MODEL 3037, LOT# NJD098229N.| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD098229N| LEAD: MODEL 3093, LOT# V380835