BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 3905865 · Received July 1, 2014

    Report

    Report Number
    3004209178-2014-12339
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Report Date
    June 9, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 97754, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 97740, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 977A275, SERIAL# (B)(4), IMPLANTED: 2014 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 977A275, SERIAL# (B)(4), IMPLANTED: 2014 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOR ¿AT LEAST A WEEK MAYBE MORE¿ WHEN TRYING TO TURN ON STIMULATION THE PATIENT OBSERVED THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY DISCHARGED STATE SCREEN ON THE PATIENT PROGRAMMER. THE PATIENT STATED ¿IT SEEMED TO BE CUTTING ITSELF OFF.¿ IT WAS NOTED THAT ON ¿SATURDAY¿ THE PATIENT HAD IT ON ¿THEN HE TOOK TWO STEPS AND ALL OF THE SUDDEN IT WAS GONE.¿ IT WAS NOTED THAT THE STIMULATION HAD NOT BEEN ON SINCE THAT TIME. THE PATIENT NOTED THAT HE ¿COULD NOT GET THIS THING WORKING.¿ THE PATIENT NOTED THAT HE SPOKE TO THE MANUFACTURER REPRESENTATIVE THE MORNING OF REPORT AND STATED THAT THE MANUFACTURER REPRESENTATIVE THOUGHT THAT THE PATIENT WAS NOT CHARGING THE IMPLANTABLE NEUROSTIMULATOR (INS) PROPERLY. THE PATIENT NOTED THAT HE RECHARGED ¿ALL LAST NIGHT¿ BUT COULD NOT TURN STIMULATION ON. THE PATIENT NOTED THAT THE BATTERY WAS LESS THAN A QUARTER FULL. IT WAS ALSO NOTED THAT THERE WAS A COUPLING PROBLEM. THE PATIENT NOTED THAT THE COUPLING BARS CHANGED FROM TWO TO EIGHT EVEN THOUGH HE WAS NOT MOVING. THE PATIENT STATED HE WOULD LIE ON THE RECHARGER WHEN RECHARGING. WHEN THE PATIENT WAS STANDING HE COULD ACQUIRE EIGHT COUPLING BARS. HOWEVER, WHEN HE WENT TO LAY DOWN COUPLING DECREASED. THE PATIENT NOTED THAT HE HAD THESE PROBLEMS ¿BACK AND FORTH FOR MAYBE A WEEK.¿ ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT COULD NOT TURN STIMULATION ON AND THERE WAS NO STIMULATION SENSATION. THE PATIENT WAS TRYING TO USE THE RECHARGER TO TURN STIMULATION ON AND WAS NOT ABLE TO DO SO. THE PATIENT ALSO STATED THE BATTERY WAS "VERY LOW." IT WAS NOTED THAT WHEN THE PATIENT TRIED TO TURN THE STIMULATION ON WHILE CHARGING HE OBSERVED THE LOW BATTERY SCREEN. THE PATIENT TRIED TO USE THE PATIENT PROGRAMMER AND OBSERVED THE POOR COMMUNICATION SCREEN. THE PATIENT NOTED THAT HE WAS SEEING THE REGULAR RECHARGING SCREEN ON THE RECHARGER. THE PATIENT WAS ADVISED TO CONTINUE TO CHARGE UNTIL THE BATTERY WAS NOT EMPTY AND THEN TRY TO TURN ON STIMULATION. THE PATIENT DID NOT HAVE A PHYSICIAN AT THIS TIME. THE PATIENT STATED THAT THE DOCTOR "LEFT DOWN." IT WAS LATER REPORTED THAT THE PATIENT HAD NOT RECEIVED A CARD TO SHOW THAT THEY COULD HAVE AN MRI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383198 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR