BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3031427 · Received April 2, 2013

    Report

    Report Number
    3004209178-2013-04501
    Event Type
    Injury
    Date Received
    April 2, 2013
    Report Date
    March 14, 2013
    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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 37746 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 3986A LOT# N339616, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3986A LOT# N320733, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3708240 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION. (B)(4) .

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    F10. ADDITIONAL PATIENT CODE C50526. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS "IN A LOT OF PAIN". THE PATIENT HAD GOTTEN HOME FROM THE EMERGENCY ROOM AND WAS "DOPED UP" AND A LOT OF PAIN MEDICATION SUCH AS "VICODIN AND OTHER STRONG MEDICATIONS". IT WAS STATED THAT THE STIMULATOR HAD NOT HELPED THE PATIENT AND IT HAD BEEN THAT WAY FOR "ABOUT 2 MONTHS". IT WAS STATED THAT THE PATIENT TRIED TO "OVERDOSE" BY TAKING ALL THE PAIN MEDICATION HE COULD FIND. THAT PUT THE PATIENT IN INTENSIVE CARE FOR TWO WEEKS. IT WAS REPORTED THAT THE PATIENT DOES NOT FEEL STIMULATION. IT WAS UNKNOWN HOW LONG IT HAS BEEN SINCE THE PATIENT HAS FELT STIMULATION AS THE PATIENT DOES NOT COMMUNICATE VERY MUCH "EXCEPT WHEN HE SCREAMS IN PAIN". IT WAS STATED THAT THE STIMULATOR WAS ON AND AT 3.0 V. THE STIMULATION WAS INCREASED TO 3.1 V BUT THAT WAS THE UPPER LIMIT AND THE PATIENT COULD NOT INCREASE STIMULATION ANY MORE. ONE WEEK LATER, IT WAS REPORTED FROM THE HEALTH CARE PROVIDER (HCP) THAT THE CAUSE OF THE EVENT WAS UNKNOWN. IT WAS UNKNOWN IF THE PATIENT REQUIRE HOSPITALIZATION. IT WAS REPORTED THAT "THE PATIENT HAD NOT BEEN SEEN FOR THAT COMPLAINT".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD HORRIBLE HEADACHE PAIN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERAPY HELPED IN THE BEGINNING BUT IT HADN'T WORKED FOR ABOUT A YEAR. IT WAS AS IF THE PATIENT WENT THROUGH THE SURGERY FOR NOTHING BECAUSE NOTHING WAS WORKING. IT WAS REPORTED THAT THE PATIENT WAS IN PAIN ALL THE TIME AND THEY WERE CONCERNED THAT THE PATIENT WOULD DO SOMETHING DRASTIC. IT WAS REPORTED THAT STIMULATION WAS TURNED OFF AND WHEN IT WAS TURNED BACK ON THE PATIENT DID NOT FEEL STIMULATION SENSATION AT 2.8 V. THE STIMULATION WAS INCREASED TO 3.00 V AND THE PATIENT STILL DID NOT FEEL IT. IT WAS REPORTED THAT THEY WERE UNABLE TO INCREASE BEYOND 3.00 V BECAUSE THEY SAW THE UPPER LIMIT SCREEN. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S HEALTH CARE PROVIDER WAS AWARE OF THE PATIENT'S ISSUE. THEY WOULD BE DOING A CRANIOTOMY AND DOING A REVISION OF LEAD PLACEMENT. IT WAS NOTED THAT THE REVISION WAS NOT SCHEDULED YET.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS PLACEMENT OF THE SPINAL CORD STIMULATION (SCS) LEADS. IT WAS NOTED THAT SURGERY WAS PENDING. THERE WERE NO DIAGNOSTICS PERFORMED AND NO MALFUNCTIONS SEEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134603 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R