BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 2770604 · Received October 3, 2012

    Report

    Report Number
    3004209178-2012-08833
    Event Type
    Injury
    Date Received
    October 3, 2012
    Report Date
    September 7, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3776-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3550-29, LOT# N311900, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS LEAD MIGRATION AND FACET JOINT PAIN. THERE WERE NO ABNORMAL IMPEDANCE MEASUREMENTS AND REPROGRAMMING WAS DONE ON (B)(6) 2012. THE PATIENT HAD NO LEFT SIDE RELIEF BECAUSE THE LEAD MIGRATED TO THE LEFT, SO ONLY HAD RIGHT SIDE COVERAGE. THE PATIENT WAS TO BE REPROGRAMMED AGAIN IN NOVEMBER AND LEAD REVISION WAS PLANNED "SOON," BUT NOT SCHEDULED. THE PATIENT ALSO RECEIVED TWO THORACIC (B)(6) ON (B)(6) 2012 AND (B)(6) 2012 THAT PROVIDED "GREAT" PAIN RELIEF. RADIOFREQUENCY WAS ALSO PERFORMED ON (B)(6) 2012. HOSPITALIZATION WAS NOT REQUIRED AND THE PATIENT SUSTAINED NO INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "PRIOR TO AN INJECTION" THE PATIENT WAS EXPERIENCING STIMULATION IN THE WRONG LOCATION. THE PATIENT HAD ALL RIG HT SIDE STIMULATION AND HIS PAIN WAS ALL LEFT SIDE. REPROGRAMMING THE DEVICE WAS UNSUCCESSFUL. THE PHYSICIAN WAS GOING TO REVISE THE LEAD AND ADD A SECOND LEAD. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention