BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 2053585 · Received March 1, 2011

    Report

    Report Number
    3004209178-2011-01515
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 11, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    RECEIVED INFO THE PT WAS EXPERIENCING INTERMITTENT STIMULATION DUE TO LOW BATTERY. INTERROGATION OF THE DEVICE REPORTED THE BATTERY WOULD SOMETIMES READ LOW AND OTHER TIMES OKAY. PERFORMED LONGEVITY CALCULATION TO ESTIMATES INS BATTERY LIFE, .045V/450PW/50HZ. THERAPY IMPEDANCE 955OHMS, 2 ANODES AND 2 CATHODES. THE PHYSICIAN REPLACED THE BATTERY AND MFR REP REPORTED GETTING (???) MARKS IN THE RESULTS. THE TEST WAS RE-RUN USING A HIGHER DEFAULT SETTING AND IMPEDANCES WERE >4000 OHMS ON SOME BIPOLAR PAIRS. THE PHYSICIAN WIPED DOWN THE CONNECTIONS WITHOUT SUCCESS. PHYSICIAN DECIDED TO WAIT AND RETEST PT LATER. MFR REP REPORTS THE PT EXPERIENCED A SHOCKING SENSATION IN THE POCKET DURING DIAGNOSTIC TESTING PRIOR TO INS REPLACEMENT. PT WAS NOT PROGRAMMED CASE POSITIVE BUT THIS MOST LIKELY OCCURRED DURING IMPEDANCE TESTING WITH THE CASE CONFIGURATIONS. ADD'L 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 ITREL 3 LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 7425 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3587A, LOT # L89418| IMPLANTED:| PROGRAMMER: MODEL 7434A, LOT # NGL038266P| PROGRAMMER: MODEL 7434, LOT # YN0047005P| EXTENSION: MODEL 7495-25, LOT # NAF018396N| EXPLANTED:| IMPLANTED:| LOT # NAT134527H| IMPLANTABLE NEURO STIMULATOR: MODEL 7425,