BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3904652 · Received July 1, 2014

    Report

    Report Number
    3004209178-2014-12315
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Report Date
    June 5, 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
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO ADJUST STIMULATION AND THAT DISPLAY WAS SHOWING THE CALL YOUR DOCTOR ICON. IT WAS ALSO REPORTED THAT THERE WAS A POWER ON RESET (POR) CONDITION. THE PATIENT WAS WALKED THROUGH HOW TO CLEAR THE POR. IT WAS NOTED THAT THE PATIENT SAW THIS ON THE DAY OF THE REPORT. THE PATIENT WAS REPORTEDLY FEELING STRANGE ON THE DAY PRIOR TO THE REPORT AND WANTED TO KNOW IF THIS COULD BE RELATED. THE PATIENT WAS ASKED TO BE MORE SPECIFIC AND THEY STATED THAT THEY HAD PAINFUL AND PRICKLY SENSATION AROUND THE IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS NOTED THAT A FAMILY MEMBER TOOK A LOOK AND THERE WAS NO SWELLING. IT WAS LATER REPORTED THAT THE PATIENT RECEIVED ASSISTANCE FROM A MANUFACTURER REPRESENTATIVE OR THEIR DOCTOR AND THEIR CONCERNS WERE RESOLVE; THAT THEY WERE STILL HAVING CONCERNS WITH THEIR DEVICE OR THERAPY AND ARE WORKING WITH A MANUFACTURER REPRESENTATIVE OR THEIR DOCTOR; AND THAT THEY WERE STILL HAVING CONCERNS WITH THEIR DEVICE OR THERAPY AND HAVE NOT SOUGHT FURTHER HELP. IT WAS NOTED THAT THE PATIENT HAD AN APPOINTMENT ON (B)(6) 2014.

    Description of Event or Problem · 1

    WHEN CONTACTED FOR FOLLOW UP INFORMATION, THE HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE PATIENT'S PHYSICIAN HAD RETIRED AS OF (B)(6) 2014. IT WAS NOTED THAT THE PATIENT WAS LAST SEEN ON (B)(6) 2013 AND THAT THERE WAS NO EXPLANT BY THE DOCTOR. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383218 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