BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3071445 · Received April 22, 2013

    Report

    Report Number
    3004209178-2013-06683
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    April 6, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 39286-30, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT COULD NOT TURN THE STIMULATOR ON. THE PATIENT DIDN¿T KNOW WHY IT THEIR INS WOULDN¿T CHARGE.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION REPORTED THAT THE MANUFACTURER¿S REPRESENTATIVE MET WITH THE PATIENT FOR REPROGRAMMING WHERE THE SETTINGS ON IMPLANTABLE NEUROSTIMULATOR (INS) WERE ADJUSTED AND BETTER COVERAGE ACHIEVED AFTER RE-ORIENTING THE SENSOR FEATURE. THE PATIENT ALSO MET WITH THEIR NURSE PRACTITIONER FOR MEDICAL MANAGEMENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION REPORTED THAT THE PATIENT RECEIVED ASSISTANCE THEIR DOCTOR AND THE MANUFACTURER¿S REPRESENTATIVE AND THE ISSUE WAS RESOLVED. SPECIFICALLY, THE SETTINGS (AND ¿SENSATIONS¿) ON THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WERE ADJUSTED (DATE UNKNOWN) AND THAT THEY HAVE HAD NO FURTHER PROBLEMS SINCE. THE PATIENT NOTED ¿SO FAR EVERYTHING IS RUNNING FINE¿. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A POWER-ON RESET (POR) CONDITION ON THEIR DEVICE. IT WAS ALSO STATED THE PATIENT TOUCHED THE NAVIGATOR BUTTON AND RE-SYNCED THEIR DEVICE. THE PATIENT WAS THEN ABLE TO CHARGE AND IT WAS REPORTED THE ISSUE WAS SOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172587 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 00043 YR