BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 4078102 · Received September 10, 2014

    Report

    Report Number
    3004209178-2014-16724
    Event Type
    Malfunction
    Date Received
    September 10, 2014
    Report Date
    April 1, 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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3888-45, LOT# V871891, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD; PRODUCT ID 37754, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: RECHARGER; PRODUCT ID 37744, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION; PRODUCT ID 3888-45, LOT# V871891, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE EPIDURAL LEAD HAD BEEN TURNED OFF IN ORDER TO SAVE BATTERY CHARGE AS THE LEAD HAD HAD HIGH IMPEDANCES AND THE PATIENT WASN¿T RECEIVING PARESTHESIA IN THE BUTT OR LEGS. THE PATIENT HAD COVERAGE OF THE LOWER BACK, BUT NEEDED COVERAGE OF THE BUTT AND LEGS. THE PATIENT WAS GOING TO SCHEDULE AN APPOINTMENT WITH A MANUFACTURER REPRESENTATIVE TO VERIFY THAT THE IMPEDANCES WERE HIGH AND TO SEE IF THE PARESTHESIA COULD BE RECOVERED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS CALLING TO SCHEDULE AN APPOINTMENT WITH THE MANUFACTURER REPRESENTATIVE FOR REPROGRAMMING. THE PATIENT NEEDED TO BE REPROGRAMMED BECAUSE THE STIMULATION WAS NOT WORKING AND HAD NOT WORKED FOR OVER A MONTH. ABOUT A MONTH AGO THE PATIENT TURNED OFF THE IMPLANTABLE NEUROSTIMULATOR (INS) BECAUSE THE STIMULATION WAS NOT WORKING AND THE PATIENT DIDN¿T TURN IT BACK ON. IT WAS LATER REPORTED THAT THE PATIENT WAS HAVING CONCERNS, AND WAS SEEKING ASSISTANCE, BUT DID NOT HAVE A SCHEDULED APPOINTMENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MANUFACTURING REPRESENTATIVE MET WITH THE PATIENT IN (B)(6) 2013. AT THAT TIME, THEY DISCOVERED THE PATIENT HAD ONE EPIDURAL LEAD AND TWO SUBCUTANEOUS LEADS FOR THE LOW BACK PAIN. IT WAS DETERMINED THAT SOMETHING WAS WRONG WITH THE EPIDURAL LEAD AS THERE WAS NO COVERAGE WHEN USING IT AND HIGH IMPEDANCES. THEREFORE THE EPIDURAL LEAD WAS TURNED OFF AT THAT TIME. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD AN APPOINTMENT SCHEDULED ON (B)(6) 2014. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS REPROGRAMMED. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FO LLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558666 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 00048 YR