BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 2101708 · Received May 11, 2011

    Report

    Report Number
    3004209178-2011-03416
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 14, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    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

    IT WAS REPORTED THAT AFTER A FALL, THE PATIENT HAD NO STIMULATION AND A LOSS OF THERAPEUTIC EFFECT. THE PATIENT FELL OVER A RECLINER AND LANDED ON THEIR SIDE. AN X-RAY WAS TAKEN, BUT IT WAS UNKNOWN THE EXACT LOCATION OF THE X-RAY. IMPEDANCE READINGS WERE ALSO GREATER THAN 4000 OHMS ON ALL OF THE UNIPOLAR PAIRS. THE NEED FOR SURGICAL REVISION WAS REVIEWED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL 3 LGW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 7425 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3487A, LOT# J0309612V| EXTENSION: MODEL 7489, LOT# NHU002458V| PROGRAMMER: MODEL 7434A, LOT# NGL010915P