BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL II

    MDR report key: 1327900 · Received February 27, 2009

    Report

    Report Number
    6000032-2009-01399
    Event Type
    Injury
    Date Received
    February 27, 2009
    Report Date
    February 5, 2009
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 7495-66, SERIAL# (B)(4), IMPLANTED: (B)(6) 1993, EXPLANTED: (B)(6) 2001, PRODUCT TYPE: EXTENSION. PRODUCT ID NEU_UNKNOWN_LEAD, LOT# *UK6092295, PRODUCT TYPE: LEAD. PRODUCT ID NEU_UNKNOWN_LEAD, LOT# *UK 6092295, PRODUCT TYPE: LEAD. PRODUCT ID NEU_UNKNOWN_LEAD, LOT# *UK6074933, IMPLANTED: (B)(6) 1996, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE THREE REVISIONS. NO PATIENT SYMPTOMS WERE REPORTED. THE DETAILS OF THE REVISION WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. REFERENCE MFR REPORT #6000032-2009-01398, 6000032-2009-01400.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT'S WIRES BROKE 10-12 YEARS AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL II LGW MDT SOFAMOR DANEK PUERTO RICO MFG 7424 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED:| LEAD: MODEL UNKNOWN| EXTENSION: MODEL 7495| IMPLANTED:| IMPLANTED:| EXPLANTED: