BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 3843262 · Received June 2, 2014

    Report

    Report Number
    3004209178-2014-09957
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 11, 2014
    Report Date
    May 12, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37742, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 399930, LOT# V013334, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MANUFACTURER REPRESENTATIVE MET WITH THE PATIENT ON (B)(6) 2014. IT WAS NOTED THE CAUSE OF THE EVENT WAS DETERMINED AND WAS DEVICE RELATED. IT WAS NOTED THAT THE PATIENT PROGRAMMER WAS MALFUNCTIONING AND THE MANUFACTURER REPRESENTATIVE WAS ABLE TO TURN OFF THE IMPLANTABLE NEUROSTIMULATOR (INS) WITH THE CLINICIAN PROGRAMMER. A NEW PATIENT PROGRAMMER WAS LATER MAILED TO THE PATIENT AND IT WORKED. ON (B)(6) 2014, THE MANUFACTURER REPRESENTATIVE MET THE PATIENT AGAIN TO FOLLOW-UP. IT WAS NOTED THAT IMPEDANCES WERE ALL WITHIN NORMAL LIMITS AND THE NEW REMOTE WAS WORKING PROPERLY. IT WAS NOTED THAT PROGRAMMING WAS NOT NEEDED. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED AN ERROR MESSAGE ON THE ¿CONTROLLER¿ AND WAS UNABLE TO ADJUST. THE ERROR OR ISSUE WAS UNKNOWN. IT WAS LATER REPORTED THAT THERE WAS A PROBLEM WITH THE PATIENT PROGRAMMER. THE CALLER STATED THAT STIMULATION WAS INCREASED THE NIGHT OF REPORT DUE TO INCREASE IN BACK PAIN. THEN, THE PATIENT WANTED TO TURN IT BACK DOWN BUT REPORTED THAT THEY WERE UNABLE TO DO SO. AS A RESULT, THE PATIENT WAS UNABLE TO SLEEP. DURING THE CALL THE PATIENT ALSO STATED THAT THEIR BACK HURT. DURING INITIAL TROUBLESHOOTING THE PATIENT STATED THAT AFTER THEY PRESSED THE SYNCH KEY THE SCREEN WENT BLANK. IT WAS NOTED THAT SUPER HEAVY DUTY BATTERIES WERE BEING USED. THE PATIENT WOULD CALL BACK WITH AN UPDATE AFTER REPLACING WITH ALKALINE BATTERIES. IT WAS LATER REPORTED THAT A ¿CALL YOUR DOCTOR¿ DISPLAY WAS OBSERVED AND THE CALLER WAS NOT ABLE TO ADJUST STIMULATION. THE PATIENT NOTED THAT THEY INCREASED STIMULATION ON THE DATE OF REPORT BECAUSE THEY HAD BACK PAIN AND THEN WAS NOT ABLE TO DECREASE IT AND ¿IT WAS GOING CRAZY.¿ THE PATIENT OBSERVED A DOCTOR SCREEN (B)(6) 2014 AND THEN OBSERVED THE ¿MANUFACTURER SCREEN.¿ IT WAS NOTED THAT THE PATIENT COULD NOT TURN OFF THE IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT NOTED THAT THEY WENT TO THE STORE AND ACQUIRED NEW BATTERIES AND IT WAS STILL GIVING THE MANUFACTURER SCREEN. THE PATIENT STATED THAT THERE WAS NO CORROSION. THE PATIENT STATED THAT THEY NEEDED THE INS OFF. IT WAS NOTED THAT WHILE PATIENT SERVICES WAS TALKING TO THE PATIENT THE MANUFACTURER REPRESENTATIVE CALLED. THE PATIENT HAD CONTACTED THE DOCTOR AND THE DOCTOR HAD CONTACT THE MANUFACTURER REPRESENTATIVE AND WAS GOING TO TRY TO MEET THE PATIENT AND TURN OFF THE INS. IT WAS FURTHER REPORTED THAT THE PATIENT PROGRAMMER HAD MANUFACTURER SCREEN DISPLAYED. THE PATIENT COULD NOT GET ANY OTHER SCREEN TO DISPLAY. THERE WAS NO SIGN OF CORROSION. THE ANOMALY APPEARED TO HAVE OCCURRED THROUGH PRODUCT USE.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE COMPLAINT RELATED TO (B)(4) WAS UNKNOWN. ANALYSIS OF THE PATIENT PROGRAMMER SERIAL NUMBER (B)(4) FOUND THAT THE TELEMETRY BOARD WAS CORRODED. IT WAS NOTED THAT THE TELEMETRY BOARD WAS REPLACED THAT HAD CORROSION AND A BROKEN JACK. THE BOTTOM CASE ASSEMBLY WAS CORRODED AND THE CASE FRONT WAS DIRTY. IT WAS NOTED THAT THE KEYBOARD WAS DISCOLORED. THE DIRTY AND DISCOLORED BUTTONS WERE REPLACED. IT WAS ALSO NOTED THAT THE FACE PLATE HAD GENERAL MAINTENANCE. IT WAS LATER REPORTED THAT THE PATIENT PROGRAMMER (B)(4) WAS FOUND TO BE OUT OF SPECIFICATION.

    Description of Event or Problem · 1

    ANALYSIS OF THE PATIENT PROGRAMMER (S/N (B)(4)) FOUND THE DIGITAL BOARD WAS CORRODED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321669 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR