BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 3883793 · Received June 19, 2014

    Report

    Report Number
    9614453-2014-01513
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 30, 2014
    Report Date
    May 30, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE EXTENSION FOUND NO SIGNIFICANT ANOMALY. IT WAS NOTED THE CONNECTOR ON THE PROXIMAL END OF THE EXTENSION WAS CUT. ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR FOUND NO SIGNIFICANT ANOMALY. IT WAS NOTED THE BATTERY WAS NOT IN NEW CONDITION.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID: 7482-51, SERIAL# (B)(4), EXPLANTED: (B)(6) 2014,PRODUCT TYPE: EXTENSION. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH IMPEDANCE VALUES WERE MEASURED PRIOR TO THE EXPLANT OF THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS STATED THE INS AND EXTENSION WERE REMOVED AT THE TIME OF REPORT AND THAT THE INS WOULD BE REPLACED THE WEEK AFTER REPORT. IT WAS NOTED THERE WAS ¿NO¿ HEALTH HAZARD TO THE PATIENT AS A RESULT OF THE EVENT. ADDITIONAL INFORMATION INDICATED A NEW INS WAS IMPLANTED ON (B)(6) 2014. IT WAS NOTED THE PATIENT HAD ¿RECOVERED¿ AND WAS DISCHARGED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361901 ITREL 3 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW IPG MFG SWITZERLAND 7425

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention