BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 2579198 · Received May 17, 2012

    Report

    Report Number
    3004209178-2012-03455
    Event Type
    Injury
    Date Received
    May 17, 2012
    Report Date
    May 18, 2016
    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
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3998, LOT # V062321, IMPLANTED: (B)(6) 2007, EXPLANTED: NA, PRODUCT TYPE LEAD. PRODUCT ID 389033, LOT # V053080, IMPLANTED: (B)(6) 2007, EXPLANTED: NA, PRODUCT TYPE LEAD. PRODUCT ID 37742, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER. PRODUCT ID 3708260, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: NA, PRODUCT TYPE EXTENSION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT REPORTED THAT FOLLOWING THE BRAIN MRI "SOMETHING HAPPENED, THEY DIDN'T USE THE RIGHT MACHINE OR SOMETHING, AND THEY "FRIED" THE PATIENT'S STIMULATOR AND IT STOPPED WORKING. THE HEALTH CARE PROVIDER REMOVED THE PREVIOUS IMPLANTABLE NEUROSTIMULATOR AND REPLACED IT WITH A NEW IMPLANTABLE NEUROSTIMULATOR. AT THE SAME TIME OF THE IMPLANTABLE NEUROSTIMULATOR REPLACEMENT, THEY ADDED ANOTHER SET OF LEAD WIRES AND "LOOPED THEM IN, BUT DIDN'T IMPLANT THEM." SINCE THE IMPLANTABLE NEUROSTIMULATOR WAS REPLACED, A LOT OF OTHER THINGS HAVE HAPPENED." THIS WAS DESCRIBED AS THE PATIENT BEING DIAGNOSED WITH UNRELATED CHRONIC PANCREATITIS AND SHE ALSO HAD WHIPPLE SURGERY. THE PATIENT'S MANAGING HEALTH CARE PROVIDER RECOMMENDED THAT THE PATIENT BE ABLE TO GET MRIS DUE TO THESE HEALTH ISSUES, AND THE PATIENT NEEDS MRIS OF HER STOMACH AND CHEST WHICH IS UNRELATED TO THE DEVICE OR THERAPY. THE PATIENT IS DISCUSSING THE POTENTIAL OF REPLACING HER CURRENT SYSTEM COMPLETELY WITH AN MRI COMPATIBLE SYSTEM. THERE WERE NO PLANNED SURGICAL INTERVENTIONS.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT RECEIVED ADDITIONAL HELP ON (B)(6), 2012 AND THE ISSUES RESOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) TURNED SIDEWAYS WITH THE BOTTOM "STICKING OUT" FOLLOWING A BRAIN MRI. IT WAS NOTED THAT THE PATIENT NEEDED THE MRI FOR MEMORY ISSUES. ALSO, THE PATIENT WAS UNABLE TO TURN THE INS ON WITH THE PATIENT PROGRAMMER (WITH OR WITHOUT THE ANTENNA ATTACHED) AFTER THE MRI. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME 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 48 YR Required Intervention