BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 5794444 · Received July 14, 2016

    Report

    Report Number
    3004209178-2016-14226
    Event Type
    Injury
    Date Received
    July 14, 2016
    Date of Event
    August 25, 2012
    Report Date
    July 14, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3888-45, LOT# V871889, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. MEDTRONIC, INC. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A CONSUMER IMPLANTED FOR SPINAL PAIN, NON-MALIGNANT PAIN, AND FAILED BACK SURGERY SYNDROME REPORTED THEY STARTED GETTING SICK ABOUT A MONTH AFTER IMPLANT. A FEW MONTHS LATER THEY NOTICED PUS NEAR THE INCISION SITE. IT WAS DETERMINED THE CONSUMER DEVELOPED A STAPH INFECTION ALONG THE LEAD SO THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS REMOVED A YEAR OR TWO AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447101 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention