BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 2851475 · Received November 29, 2012

    Report

    Report Number
    3004209178-2012-10942
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Report Date
    November 3, 2012
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 39286-65 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37754 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID, 37744 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS SHUTTING OFF "RANDOMLY." IT WAS STATED THAT THE INS BATTERY LEVEL WAS "OK" AND THAT IT WAS NOT THE REASON FOR THE STIMULATION TURNING OFF. IT WAS NOTED THAT THE EVENT, WHICH WAS "RANDOM IN NATURE," OCCURRED THE DAY PRIOR TO THE REPORT AS WELL AS THE DAY OF THE REPORT. IT WAS UNCERTAIN WHETHER OR NOT THE CHANGES IN STIMULATION WERE POSITIONAL, BUT IT WAS SUGGESTED THAT IT WAS NOT RELATED TO MOVEMENT. IT WAS STATED THAT THE PATIENT DID NOT SEE "ANY UNUSUAL" CODES ON THE PATIENT PROGRAMMER OR RECHARGER. IT WAS NOTED THAT THE ADAPTIVE STIMULATION WAS NOT ENABLED YET. ADDITIONAL INFORMATION WAS REQUESTED AND IF RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S DEVICE WAS "GOING OFF" AND THAT IT WAS DUE TO "POSTURE CHANGES". THE AMPLITUDE WAS INCREASED AND THE STIMULATION REMAINED ON WITH MOVEMENT. IT WAS STATED THAT THE PATIENT WAS "DOING VERY WELL AND HAPPY WITH THE STIMULATION". NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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