BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 2804299 · Received October 25, 2012

    Report

    Report Number
    3004209178-2012-09517
    Event Type
    Injury
    Date Received
    October 25, 2012
    Report Date
    September 26, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3998, LOT# V041066, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD PRODUCT ID 37083-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION PRODUCT ID 37083-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP REPORTED THE PATIENT DID NOT HAVE CONCERNS WITH THEIR DEVICE OR THERAPY. NO FURTHER INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    A LOSS OF THERAPY AND A SUBSEQUENT IMPLANT REPLACEMENT WAS REPORTED. IN (B)(6) 2012, A LOSS OF THERAPEUTIC EFFECT AT THE LEAD LOCATION WAS STATED. THE PATIENT DESCRIBED STIMULATION TO BE NOT "AS STRONG AS IT USED TO BE." THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THE COMPLAINT. IT WAS STATED AN ICON INDICATING LOW BATTERY WAS SEEN ON THE PATIENT PROGRAMMER, NO "CALL HCP-ERI" SCREEN WAS PRESENT THOUGH. FIVE MONTHS LATER, THERAPY WAS REPORTED TO HAVE STOPPED WORKING, SO "THE INS AND FOR SURE ONE LEAD WERE REPLACED." THE REPORTER SAID THE BATTERY WAS CHECKED AND "IT WAS NOT DEAD." ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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