BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 2582390 · Received May 21, 2012

    Report

    Report Number
    3004209178-2012-03555
    Event Type
    Malfunction
    Date Received
    May 21, 2012
    Report Date
    April 1, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 748966, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005. PRODUCT TYPE: EXTENSION: PRODUCT ID 74001, LOT# N213635, IMPLANTED: (B)(6) 2010. PRODUCT TYPE: ADAPTER: PRODUCT ID 3986A, LOT# LC1673, IMPLANTED: (B)(6) 2005. PRODUCT TYPE: LEAD: PRODUCT ID 37743, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3550-09, LOT# LB7167, IMPLANTED: (B)(6) 2005. PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SEVERE BURNING SENSATION "FROM THE INSIDE OUT" AT THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE THAT BEGAN FOUR DAYS BEFORE THE REPORT. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THE EVENT. IT WAS ALSO REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT AND HAD NOT HAD STIMULATION FOR ABOUT ONE MONTH PRIOR TO THE REPORT. THE PATIENT COULD ONLY FEEL STIMULATION WHEN SHE TILTED HER HEAD STRAIGHT UP TO THE CEILING. 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