BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 2951366 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01515
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 22, 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 Location
    IA, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; 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

    FOLLOW UP INFORMATION RECEIVED REPORTED THAT THE PATIENT'S BACK PAIN (LOCATED AT LUMBAR SPINE) WAS A RECURRENT PROBLEM AND CONFIRMED THAT THE CURRENT EPISODE WAS ASSOCIATED WITH A MOTOR VEHICLE ACCIDENT. THE PROBLEM WAS GRADUALLY GETTING WORSE AND WAS DESCRIBED AS A 'SHOOTING AND STABBING' SENSATION THAT RADIATES TO THE LEFT LEG. THE PATIENT AMBULATED WITH DIFFICULTY. THE PAIN WAS NOTED AS A '10' ON A SCALE OF 10. THE SYMPTOMS WERE AGGRAVATED WITH TWISTING, BENDING, AND CERTAIN OTHER POSITIONS. NEUROLOGICAL EXAMINATION WAS NEGATIVE FOR TINGLING, NUMBNESS, AND PARASTHESIA. THE PATIENT HAD TRIED MUSCLE RELAXANTS AND NSAID FOR THE PAIN BUT PROVIDED NO RELIEF. X-RAYS SHOWED VERTEBRAL ALIGNMENT WAS NORMAL WITH MODERATE DISC SPACE NARROWING ATL5-S1. THERE WAS PARTIAL LUMBARIZATION OF S1. THERE WAS NO EVIDENCE OF FRACTURES. IT WAS REPORTED THAT NO DIAGNOSTIC TESTS COULD BE PERFORMED ON THE IMPLANTABLE NEUROSTIMULATOR (INS) DUE TO 'NO BATTERY CHARGE.' THE PATIENT WAS DIAGNOSED WITH LUMBAR STRAIN AND THEIR PROGRESS WAS NOTED AS STABLE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED LOW BACK PAIN WHICH RADIATED DOWN THE PATIENT'S LEFT LEG. THE PAIN STARTED 3 DAYS AFTER A CAR ACCIDENT AROUND (B)(6) 2013 BUT HAD BEEN GETTING CONSIDERABLY WORSE OVER TIME. THE REPORTER DIDN'T KNOW IF THE PATIENT HAD TRIED TURNING STIMULATION OFF TO SEE IF THE PAIN WENT AWAY OR STAYED THE SAME. IT WAS NOTED THAT THE PATIENT HAD BEEN ADMITTED TO THE EMERGENCY ROOM. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT STILL HAD ISSUES. THE PATIENT STATED THAT THE DEVICE HAD STOPPED WORKING FOLLOWING THE PREVIOUSLY REPORTED CAR ACCIDENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56885 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 39 YR