BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 4093982 · Received September 16, 2014

    Report

    Report Number
    3004209178-2014-17141
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    July 7, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED (B)(6) 2014, WAS HOSPITALIZED RIGHT AFTER FOR FOUR DAYS DUE TO ¿COMPLICATIONS WITH THE MEDICATION¿, AND THEN SENT TO REHAB FOR SEVERAL WEEKS. THERE WAS ALSO A REPORT OF ¿FALLING ASLEEP.¿ IT WAS NOTED THAT ¿THEY¿ STOPPED ONE OF THE PATIENT¿S MEDICATION THAT HELPED THE LIVER BUT CAUSED DIARRHEA. THE PATIENT WENT 24 HOURS WITHOUT THE MEDICATION DUE TO THE IMPLANT OF THE NEUROSTIMULATION. IT WAS NOTED BECAUSE THE PATIENT DID NOT TAKE THE MEDICATION THE PATIENT DEVELOPED HEPATIC ENCEPHALOPATHY. DURING THE IMPLANT OF THE IMPLANTABLE NEUROSTIMULATOR (INS) THE DOCTOR HAD TO PERFORM A LEVEL TWO LAMINECTOMY BECAUSE OF ¿SO MUCH SCAR TISSUE FROM PREVIOUS SCAR TISSUES AND SURGERY TOOK A LOT LONGER TO DO.¿ THE PATIENT DECOMPENSATES ¿REALLY EASILY¿ AND THAT ¿LAST COUPLE OF TIMES¿ THE PATIENT HAD GONE INTO THE HOSPITAL DECOMPENSATION OCCURRED. THE PATIENT HAS HAD EIGHT BACK SURGERIES. THE PATIENT REPORTEDLY RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570860 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Hospitalization| R