BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 2664002 · Received July 20, 2012

    Report

    Report Number
    6000032-2012-00105
    Event Type
    Malfunction
    Date Received
    July 20, 2012
    Report Date
    June 22, 2012
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 748951, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2004; PRODUCT TYPE: EXTENSION, PRODUCT ID: 7434A, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2004; PRODUCT TYPE: PROGRAMMER, PATIENT, PRODUCT ID: 7425, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2004; PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR, PRODUCT ID: 3888ES6, LOT#: N26657, IMPLANTED: (B)(6) 2004; PRODUCT TYPE: LEAD, PRODUCT ID: 3777-75, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2008; PRODUCT TYPE: LEAD, PRODUCT ID: 37752, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2008; PRODUCT TYPE: RECHARGER, PRODUCT ID: 37743, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2008; PRODUCT TYPE: PROGRAMMER, PATIENT, PRODUCT ID: 3550-29, LOT#: N141220, IMPLANTED: (B)(6) 2008; PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELL A MONTH AGO AND STIMULATION WAS REALLY STRONG ON THE RIGHT LEG, BUT PATIENT NEEDED STIMULATION TO BE IN HER LEFT LEG TO COVER THE SCIATIC PAIN. THE PATIENT TRIED INCREASING STIMULATION ON WEDNESDAY AND IT STILL WOULD NOT GIVE HER COVERAGE. THE PATIENT WAS DIRECTED BY HER HEALTH CARE PROFESSIONAL (HCP) TO PAGE THE MANUFACTURER REPRESENTATIVE FOR PROGRAMMING. THE PATIENT WAS IN PAIN IN HER KNEE AND FOOT TOO, BUT WHEN THE SCIATIC PAIN WAS THERE IT OVERWHELMED THE OTHER PAINS. THE PATIENT WAS IN AGONY. IT WAS REVIEWED THAT THE PATIENT'S IMPLANT WAS CAPABLE OF COVERING PAIN IN ANOTHER PART OF THE BODY WITH OTHER LEADS, BUT IT WAS DEPENDENT ON HOW THE HCP USED THE SYSTEM AND THE ORIGINAL INTENTION OF THE HCP. AN X-RAY HAS NOT BEEN DONE TO DETERMINE IF THE LEAD MOVED. THE PATIENT HAS SCOLIOSIS. HER OUTCOME WAS INDETERMINATE AT THE TIME OF THIS REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS UNAVAILABLE AS OF THE DATE OF THIS REPORT. PLEASE REFER TO MANUFACTURER REPORT # 3004209178-2012-05927.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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