BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3031218 · Received April 2, 2013

    Report

    Report Number
    3004209178-2013-04492
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 3, 2013
    Report Date
    March 14, 2013
    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
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT STILL FELT THE JOLTING SENSATION WITHOUT MOVING AT ALL. HE DESCRIBED THE STIMULATION AS "STOP WORKING" THEN "STARTS AGAIN" WITHOUT MAKING ANY MOVES.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION. THE DEVICE WAS REPROGRAMMED AS A RESULT. IT WAS STATED THAT THERE WERE "UNUSUAL" IMPEDANCES MEASURED. THE IMPEDANCES MEASURED PROVIDED AN "XXX" RESULT. IT WAS UNKNOWN WHY THE IMPEDANCES SHOWED THIS RESULT. NO PATIENT SYMPTOMS WERE REPORTED IN RELATION TO THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DID NOT FEEL THE JOLTING SENSATION DURING REPROGRAMMING. HOWEVER IT WAS NOTED THAT THE PATIENT STATED THAT THEY WOULD FEEL THE JOLTING ¿WITH NO REASON AT ANY TIME.¿ IT WAS FURTHER REPORTED THAT THE PATIENT SEEMED QUITE SATISFIED WITH THE THERAPY WHEN IT WAS REPROGRAMMED BUT STILL HAD CONCERNS THAT HE WOULD HAVE THE SHOCKING SENSATION AGAIN. IT WAS NOTED THAT A ¿PRINT OUT¿ WAS DONE BUT THE IMPEDANCE TEST RESULTS ONLY SHOWED ¿XXX.¿ THE EXPLANATION FOR THESE IMPEDANCE RESULTS WAS UNKNOWN. IT WAS LATER REPORTED BY TECHNICAL SERVICES THAT THE XXX MESSAGE APPEARS WHEN THE AMPLITUDE USED TO TEST IMPEDANCES WAS NOT HIGH ENOUGH. IT WAS NOTED THAT THE TEST WAS ATTEMPTED AT 0.7V AND WAS RECOMMENDED TO MEASURE IMPEDANCES AT 3.0V.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133902 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