BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3923691 · Received July 9, 2014

    Report

    Report Number
    3004209178-2014-12756
    Event Type
    Injury
    Date Received
    July 9, 2014
    Report Date
    June 16, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37746, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 39565-65 LOT# SERIAL# (B)(4), IMPLANTED: (B)(6) 2013; PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD THEIR DEVICE REMOVED. IT WAS NOTED THAT THE PATIENT HAD THEIR DEVICE REMOVED 13 DAYS PRIOR TO THE REPORT. WHEN ASKED WHY IT WAS REMOVED THE PATIENT REPORTED THAT THEY WERE VERY UNHAPPY WITH IT. IT WAS NOTED THAT THEY HAD THE DEVICE FOR A YEAR AND IT DID NOT DO ANYTHING FOR THEM BUT GIVE THEM PAIN. 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
    399629 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Required Intervention