BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 2682462 · Received August 6, 2012

    Report

    Report Number
    3004209178-2012-06487
    Event Type
    Malfunction
    Date Received
    August 6, 2012
    Report Date
    July 9, 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
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37083-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 3587A25, LOT# N239562, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3550-29, LOT# N172485, IMPLANTED: (B)(6) 2010, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE PATIENT HAD AN INCREASE IN PAIN THAT STARTED 4 DAYS PRIOR. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THE SYMPTOMS. IT WAS REPORTED THERE WERE NO CHANGE IN SCREENS ON THE PATIENT PROGRAMMER. THE PATIENT DECREASED STIMULATION 2 MONTHS PRIOR, AND HAD NOT TRIED ADJUSTING STIMULATION WITH REGARD TO THE LOSS OF THERAPY. 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