BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 4021487 · Received August 19, 2014

    Report

    Report Number
    3004209178-2014-15555
    Event Type
    Malfunction
    Date Received
    August 19, 2014
    Report Date
    July 28, 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3888-56, LOT# V736710, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD; PRODUCT ID 3888-45, LOT# V961950, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS NOT RECEIVING ADEQUATE PAIN RELIEF. THE HEALTHCARE PROFESSIONAL (HCP) DID NOT THINK THE ALL-TERRAIN VEHICLE (ATV) ACCIDENT HAD CHANGED ANYTHING. THE X-RAY LOOKED UNCHANGED. THERE WAS DEVICE REPROGRAMMING AND THE PATIENT STATED IT WAS BETTER AND WOULD TRY. THE EVENT CAUSE WAS NOT DETERMINED. IT WAS NOTED THAT IT WAS NOT DEVICE RELATED. THE COMPONENT INVOLVED IN THE REPORTED EVENT WAS THE LEAD. IT WAS UNKNOWN IF THERE WAS A 50% OR GREATER SYMPTOM REDUCTION. THE PATIENT HAD RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD BEEN IN A ¿4 WHEELER ACCIDENT IN JUNE, WHERE HE LANDED ON HIS HEAD AND THE 4 WHEELER HAD LANDED ON HIS BACK.¿ IT WAS STATED THAT THE PATIENT HAD BEEN IN A LOT OF PAIN, SO THE STIMULATION WAS INCREASED. IT WAS STATED THAT AFTER THE PATIENT HAD INCREASED THE STIMULATION HE HAD BEGUN HAVING PROBLEMS BREATHING, SO THE STIMULATION WAS TURNED DOWN LOWER. IT WAS STATED THAT THE PATIENT¿S BLOOD PRESSURE WAS ELEVATED. IT WAS NOTED THAT THE PATIENT WAS AT THE ER AND WANTED TO KNOW IF THE PROBLEMS COULD HAVE BEEN RELATED TO THE SPINAL CORD STIMULATION (SCS). IT WAS STATED THAT THE PATIENT DID NOT THINK THAT TURNING THE STIMULATION DOWN HELPED THE PATIENT¿S SYMPTOMS. IT WAS NOTED THAT THE PATIENT¿S HEALTHCARE PROVIDER (HCP) HAD NOT CHECKED THE SCS THERAPY SINCE THE ACCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497805 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR