BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL II

    MDR report key: 3241261 · Received July 22, 2013

    Report

    Report Number
    6000032-2013-00176
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Report Date
    July 1, 2013
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3586, SERIAL# (B)(4), IMPLANTED: (B)(6) 1992, PRODUCT TYPE: LEAD. PRODUCT ID: 7496-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 1992, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT¿S HEALTH CARE PROVIDER CONFIRMED THAT THE PATIENT DID NOT REPORT ANY MALFUNCTION OR EVENT TO THEM. THE PATIENT WAS SEEN ON (B)(6) 2013 WITHOUT A COMPLAINT. A FOLLOW UP CALL TO THE PATIENT WAS GOING TO BE MADE AND THEN THE PATIENT¿S NEXT APPOINTMENT WAS ON (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD NOT WORKED FOR "15 YEARS." PATIENT NEVER HAD "POSITIVE WORKING ORDER FOR IT." SYMPTOMS OCCURRED FOLLOWING AN IMPLANT. IT WAS NOTED THE IMPLANT WAS STILL IN THE BODY AND THE PATIENT HAD BEEN MAINTAINING THE INS AS IF IT WERE ACTIVE. ADDITIONAL INFORMATION REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341250 ITREL II STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT SOFAMOR DANEK PUERTO RICO MFG 7424

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR