BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 3821776 · Received May 20, 2014

    Report

    Report Number
    3004209178-2014-09300
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    April 21, 2014
    Report Date
    April 30, 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 3887-33, LOT # V011495, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE RECHARGER; PRODUCT ID 3708340, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 37742, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3887-33, LOT # V011495, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD. (B)(6).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT¿S BATTERY WAS REPLACED. THERE WERE NO SYSTEM MALFUNCTIONS SEEN. THE PATIENT WAS RECEIVING EFFECTIVE THERAPY INTRA-OPERATIVELY AND POST-OPERATIVELY. THE BATTERY WAS AT THE NORMAL END OF LIFE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT HAD A PRE-OP CONSULTATION WITH THEIR DOCTOR AND THEY WERE SCHEDULED FOR A REVISION OR REPLACEMENT SURGERY ON (B)(6). THE PATIENT WAS NOT RECEIVING THERAPY AT THE TIME OF THE REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELL AND LOST THERAPY A WEEK AGO ON MONDAY. AN IMPEDANCE TEST WAS DONE AND NONE OF THE ELECTRODES WERE OUT OF RANGE. IT WAS FURTHER REPORTED THAT THE PATIENT HAD NO STIMULATION SENSATION. THE PATIENT ALSO HAD A LOSS OF THERAPEUTIC EFFECT. THE LOSS OF STIMULATION OCCURRED AT THE SAME TIME AS THE FALL. THE PATIENT HAD SORENESS FROM THE FALL AT THE LEAD INCISION SITE AND IN THE AREA ABOVE THEIR STIMULATOR. THE PATIENT FELL ON THEIR HIP AND BACK AND HAD SWELLING THERE BUT THE SWELLING HAD GONE DOWN. THE PATIENT WAS GIVEN MEDROL FOR PAIN AFTER THE FALL AND WAS TAKING PAIN MEDICATIONS BUT THE MANUFACTURER REPRESENTATIVE DIDN¿T THINK THE MEDICATIONS WERE AFFECTING THE PATIENT¿S ABILITY TO FEEL STIMULATION. THE PATIENT DID NOT HAVE ANY SPINAL INJURY WITH THE FALL AND THEY DID NOT HAVE ANY WEAKNESS. THE PATIENT DID HAVE PAIN IN THE BACK OF THEIR LEGS BUT THAT WAS NOT NEW PAIN FOR THE PATIENT. PALPATION WAS NEGATIVE. THE PATIENT CAME IN WITH THEIR SETTINGS AT 5.3V, 450 MICROSECONDS, AND 75 HERTZ. THEY TURNED THE STIMULATION UP TO 10.5V WITH THE PATIENT IN DIFFERENT POSITIONS AND THE PATIENT DIDN¿T FEEL STIMULATION ANYWHERE. THEY ALSO RAN AN IMPEDANCE T EST WITH THE PATIENT IN DIFFERENT POSITIONS AND THAT DID NOT CHANGE THE IMPEDANCES. THE CHARGE LEVEL OF THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS FINE. AN X-RAY OF THE LEAD SHOWED THAT IT WAS STILL IN THE ORIGINAL PLACE WITH ANTERIOR-POSTERIOR AND LATERAL VIEWS. THE IMPEDANCE RESULTS WERE: 01 = 642 807 02 = 791 770 03 = 807 714 12 = 721 13 = 770 23 = 791 721 714 IT WAS FURTHER REPORTED THAT NO MALFUNCTION WAS ABLE TO BE DIAGNOSED. THE CLINIC WAS BEGINNING THE AUTHORIZATION PROCESS FOR A REVISION OR REPLACEMENT OF THE PATIENT¿S ENTIRE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299048 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR Required Intervention