BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 2990136 · Received March 5, 2013

    Report

    Report Number
    6000032-2013-00055
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Report Date
    February 11, 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
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 749851, SERIAL# (B)(4), IMPLANTED: (B)(6) 1999. PRODUCT TYPE: EXTENSION: PRODUCT ID 7434-E, SERIAL# (B)(4), IMPLANTED: (B)(6) 1999. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 7434, SERIAL# (B)(4), IMPLANTED: (B)(6) 1999. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3487A, LOT# L65021, IMPLANTED: (B)(6) 1999. PRODUCT TYPE: LEAD: PRODUCT ID 3487A, LOT# L65021, IMPLANTED: (B)(6) 1999. PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT AND "NEEDED HER IMPLANTABLE NEUROSTIMULATOR (INS) CHANGED." IT WAS STATED THE PATIENT HAD A LOT OF MIGRAINES AND HAD A "MAJOR SURGERY" IN (B)(6) 2012. IT WAS ALSO STATED THE PATIENT WASN'T ABLE TO TURN ON HER INS SINCE (B)(6) 2012. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93352 ITREL 3 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT SOFAMOR DANEK PUERTO RICO MFG 7425

    Patients

    Seq Age Sex Outcome Treatment
    1