BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 2883303 · Received December 21, 2012

    Report

    Report Number
    3004209178-2012-12151
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Report Date
    December 3, 2012
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 748951, SERIAL # (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE EXTENSION; PRODUCT ID 748951, SERIAL # (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE EXTENSION; PRODUCT ID 7435, SERIAL # (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3998, LOT # J0424996V, IMPLANTED: (B)(6) 2004, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT RECEIVED ASSISTANCE FROM HIS DOCTOR OR MANUFACTURER REPRESENTATIVE AND HIS CONCERNS WERE RESOLVED. IT WAS NOTED THAT THE PATIENT'S NEXT APPOINTMENT WITH HIS DOCTOR WAS SCHEDULED FOR (B)(6) 2013. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT COULD STILL FEEL STIMULATION AND HIS DEVICE WAS STILL WORKING. HOWEVER, WHILE STIMULATION WAS TURNED ON AND OFF, THE PATIENT EXPERIENCED PAIN IN HIS LEFT FLANK AREA ALONG THE "WIRING SYSTEM BETWEEN WHERE THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS LOCATED AND WHERE THE LEAD WENT INTO THE SPINE." THE PAIN WAS REPORTED TO HAVE STARTED THIS PAST SUMMER, BUT THE PATIENT HAD NOT HAD ANY FALLS OR TRAUMA. THE REPORTER INDICATED THAT THE PATIENT SOMETIMES LAY ON HIS SIDE AND STRETCHED HIS ARMS AND WAS UNSURE IF HE MAY HAVE PULLED IT AWAY FROM WHERE IT WAS ANCHORED. IT WAS NOTED THAT THE PATIENT WAS NOT SO MUCH WORRIED ABOUT THIS AS MUCH AS ABOUT WHETHER THE SYSTEM COULD REMAIN IMPLANTED. THE INS WAS INDICATED TO HAVE "DROPPED DOWN" AND WAS SITTING ON TOP OF THE PATIENT'S HIP BONE. THE REPORTER STATED THAT ABOUT A YEAR PRIOR, THE PATIENT WAS SCHEDULED TO HAVE SURGERY TO "LIFT THE DEVICE BACK UP", BUT HE TOOK MEDICATION BEFORE THE PROCEDURE WHICH CAUSED THE SURGERY TO BE POSTPONED. THE PAIN FROM THAT WAS INDICATED TO HAVE GONE AWAY AND HAD NOT RETURNED, THEREFORE, THE PATIENT DID NOT HAVE THE SURGERY RESCHEDULED. IT WAS ALSO REPORTED THAT WHEN THE PATIENT MOVED OR "ADJUSTED HIS BODY" WHILE THE INS WAS ON, IT FELT "MORE LIKE A SHOCK" SO HE DIDN'T USE THERAPY ALL THE TIME AND TURNED HIS DEVICE OFF WHEN HE WAS GOING TO BE MOVING OR "SHIFTING." THE THERAPY WAS NOTED TO BE USED WHEN THE PATIENT WAS STILL AND NOT "SHIFTING" HIS SPINE. IT WAS STATED THAT THE DEVICE HAD NOT BEEN "PERFECT" AT CONTROLLING THE PATIENT'S PAIN BUT IT HELPED OUT AND HAD BEEN BETTER THAN MEDICATION ALONE. THE COMBINATION OF MEDICATION AND DEVICE HAD GIVEN THE PATIENT MANY MORE WAYS OF CONTROLLING PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427

    Patients

    Seq Age Sex Outcome Treatment
    1