BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3090360 · Received May 2, 2013

    Report

    Report Number
    3004209178-2013-07225
    Event Type
    Injury
    Date Received
    May 2, 2013
    Report Date
    April 23, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3778-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3778-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT KNEW SOMETHING WAS WRONG EVER SINCE HIS SYSTEM WAS IMPLANTED. THE PATIENT STATED THAT HE TOLD THE HCP, BUT WAS TOLD TO SEEK COUNSELING AND PSYCHIATRISTS BECAUSE "IT WAS IN HIS HEAD." THE PATIENT STATED THAT THE DEVICE WAS INFECTED AND THE INFECTION CARRIED ALL THE WAY UP THE BRAIN. THE INFECTION WENT FROM THE CERVICAL TO THE HIP. THE PATIENT BEGGED TO GO HOME AND THE HCP SENT HIM HOME WITH A PIC LINE AND AN ANTIBIOTIC INJECTION. THE PATIENT REPORTED THAT THIS "ALMOST KILLED HIM". IT WAS REPORTED THAT THE INSIDE STITCHES WAS POPPING OUT AND THE HCP CUT THE STITCHES AND PUT BANDAGES ON AND SENT THE PATIENT HOME WITHOUT MEDICATION. IT WAS ALSO REPORTED THAT THE PATIENT HAD PREVIOUS BULGE STICKING OUT OF HIS NECK FROM THE LEADS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE PATIENT GOT A ¿MASSIVE¿ INFECTION FROM THEIR IMPLANT AND THEY WERE STILL FIGHTING THE INFECTION. IT WAS STATED THE PATIENT¿S TRIAL WORKED AND THEY GOT SOME FEELING BACK IN THEIR HANDS. IT WAS NOTED THE PATIENT¿S STITCHES WERE POPPING OUT AND PUFFY BUT REPORTEDLY THE PATIENT¿S DOCTOR TOLD THEM IT WAS IN THEIR HEAD AND SENT THEM TO A PSYCHOLOGIST. IT WAS REPORTED THE PATIENT WENT TO ANOTHER DOCTOR THAT TOLD THEM THEY HAD AN INFECTION AND SHOULD GET TO THE EMERGENCY ROOM. IT WAS STATED THE PATIENT¿S WHOLE SYSTEM WAS REMOVED AND THEY CLEANED OUT WHAT THEY COULD FROM THE CERVICAL AREA. IT WAS NOTED THE PATIENT SPENT TWO WEEKS IN THE HOSPITAL AND WAS WITHOUT PAIN MEDICATION FOR TWO DAYS. REPORTEDLY, THE PATIENT STATED THEY WERE TOLD IF THEY WAITED ANOTHER 24 HOURS THEY WOULD HAVE DIED. IT WAS STATED THE PATIENT HAD TO GIVE THEMSELVES INJECTIONS OF ANTIBIOTICS AND THE INFECTION WAS IN THEIR HEAD AND EARS AND THEY HAD TROUBLE HEARING. THE PATIENT STATED THEY THOUGHT THE INFECTION WENT TO REST. IT WAS LATER REPORTED THE PATIENT STILL HAD THE INFECTION AND THEY COULD NOT GET RID OF IT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IN PAIN AND WAS SICK AFTER THE DEVICE WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192259 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 00054 YR Required Intervention