BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IITREL 3

    MDR report key: 1180883 · Received September 23, 2008

    Report

    Report Number
    6000032-2008-06036
    Event Type
    Malfunction
    Date Received
    September 23, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 28, 2008
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO, MEL REL
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE PATIENT NO LONGER FELT STIMULATION IN HIS BACK, JUST IN HIS KNEES AND TOES. WHEN HE TURNS THE STIMULATOR ON, IT GIVE HIM A BIG JOLT THEN SLOWLY DEPLETES AND THEN DIES. THE PATIENT'S SYMPTOMS WERE LOCATED AT THE PARESTHESIA AREA. THE PATIENT WAS HOME AND HIS STATUS WAS REPORTED AS "FAIR". THE PATIENT WAS IN MORE PAIN AND DIDN'T WANT TO START TAKING TOO MANY ORAL MEDICATIONS. THE PATIENT WAS ALSO UNABLE TO ADJUST HIS STIMULATION; ONLY THE 9 VOLT BATTERY LIGHT WAS LIT ON THE PATIENT PROGRAMMER. THE PATIENT WAS ENCOURAGED TO CONTACT HIS HEALTH CARE PROFESSIONAL. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IITREL 3 LGW MDT PUERTO RICO OPERATIONS CO, MEL REL 7425 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention PROGRAMMER: MODEL 7434A| EXPLANTED:| LEAD: MODEL 3587A| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7495LZ| IMPLANTED: