BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3951258 · Received July 22, 2014

    Report

    Report Number
    3004209178-2014-13392
    Event Type
    Injury
    Date Received
    July 22, 2014
    Report Date
    July 1, 2014
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3778-45, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 3778-45, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2014, PRODUCT TYPE EXTENSION; PRODUCT ID 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2014, PRODUCT TYPE EXTENSION; PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37744, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED STIMULATION/THERAPY ISSUES. THE PATIENT STATED THAT STIMULATION MADE HER FEEL ANXIOUS, MADE HER BLOOD PRESSURE INCREASE, AND MADE IT HARD FOR HER TO BREATHE. THE LOCATION OF THE PATIENT¿S SYMPTOMS WAS NOTED TO BE UNKNOWN. A FULL SYSTEM EXPLANT WAS REQUIRED AS A RESULT OF THE EVENT. IT WAS NOTED THE CAUSE OF THE ISSUE WAS UNDETERMINED. THE DATE OF IMPLANT WAS NOTED TO BE (B)(6) 2012 AND DATE OF EXPLANT WAS (B)(6) 2014. THE PATIENT¿S STATUS WAS NOTED TO BE ALIVE WITH NO INJURY. IT WAS NOTED THE PATIENT HAD A MEDICAL HISTORY WHICH INCLUDED DEPRESSION AND ANXIETY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CAUSE OF THE EVENT WAS UNKNOWN. THERE WAS NO CAUSE DETERMINED FOR THE ANXIETY, ELEVATED BLOOD PRESSURE, AND BREATHING PROBLEMS. IT WAS UNKNOWN IF THE ISSUES WERE DEVICE RELATED. ONE DOCTOR DID NOT THINK THE ISSUES WERE DEVICE RELATED AND ANOTHER DOCTOR WAS NOT SURE. THE PATIENT DID NOT FIND THEIR STIMULATOR TO BE HELPFUL. THE PATIENT HAD A PAIN PUMP IMPLANTED ON (B)(6) 2014 AND WAS BEING MANAGED BY INTRATHECAL PAIN MEDICATIONS. IT WAS NOTED THAT THE PATIENT RECOVERED WITH PERMANENT IMPAIRMENT BY ONE DOCTOR AND THAT THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT BY ANOTHER DOCTOR. IT WAS UNCLEAR IF THE PATIENT RECOVERED WITHOUT SEQUELAE OR NOT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428045 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention