BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 1111644 · Received August 13, 2008

    Report

    Report Number
    3004209178-2008-04901
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 15, 2008
    Report Date
    July 18, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAS BOTH A SPINAL CORD STIMULATOR AND A CARDIAC DEFIBRILLATOR IMPLANTED. WHEN THE DEFIBRILLATOR DELIVERED A SHOCK, IT TURNED THE PT'S SPINAL CORD STIMULATOR OFF. THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. IT WAS REPORTED THAT NOW WHEN THE PT ATTEMPTS TO TURN THE SPINAL CORD STIMULATOR ON WITH HIS PT PROGRAMMER HE ONLY GETS A TRIPLE BEEP, THE DEVICE DOES NOT TURN ON. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE HEALTHCARE PROVIDER, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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 74 YR LOT#PRL101540H| LOT#BAA088451V| EXPLANTED| IMPLANTED| IMPLANTABLE CARDIAC DEFIBRILLATOR MODEL 7303| EXPLANTED| IMPLANTED| PROGRAMMER MODEL PROGRAMMER LOT# UNK| EXPLANTED| IMPLANTED| EXTENSION MODEL 7495-25 LOT# NAF006093N| LEAD MODEL 3888 LOT# L41401| IMPLANTED| CARDIAC PACING LEAD 5076 LOT# PJN636083V| IMPLANTED| CARDIAC PACING LEAD MODEL 4193| EXPLANTED| LOT# TDG126240V| HIGH VOLTAGE DEFIBRILLATION LEAD MODEL 6947| EXPLANTED| IMPLANTED| EXPLANTED