BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 4323307 · Received December 11, 2014

    Report

    Report Number
    3004209178-2014-23797
    Event Type
    Malfunction
    Date Received
    December 11, 2014
    Report Date
    November 24, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3587A, LOT# N081381, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 3587A, LOT# N090598, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: RECHARGER. PRODUCT ID: 3708360, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WAS IN A CONFIRMED OVERDISCHARGE STATE FOR 8 MONTHS. IT WAS UNKNOWN WHY IT OCCURRED. THERE WERE ALSO TELEMETRY, RECHARGING, AND COUPLING ISSUES. A MANUFACTURING REPRESENTATIVE WAS CURRENTLY ON HIS 3RD PHYSICIAN MODE RECHARGE (PMR) AND WANTED TO KNOW IF HE STOPPED AFTER THE 3RD ONE IF HE WOULD BE ABLE TO DO MORE THE NEXT DAY WITHOUT THE HURTING THE BATTERY. THEY COMPLETED ANOTHER RESET, THE PMR WAS SUCCESSFUL, AND THE BATTERY WENT INTO CHARGE MODE. THEY ALSO SAW AN END OF SERVICE (EOS)/END OF LIFE (EOL) MESSAGE ON THE PATIENT PROGRAMMER (PP) AND CLINICIAN PROGRAMMER (8840). THE 8840 WAS DISPLAYED ¿INS IS DISCHARGED, RECHARGE NOW SCREEN.¿ THEY WERE ADVISED THAT THE INS COULD CONTINUE TO BE CHARGED BUT SINCE IT WAS AT EOS, STIMULATION WAS NO LONGER AVAILABLE. THERE WAS A MEDICAL OR THERAPY PROBLEM. A POWER ON RESET (POR) WAS CLEARED BUT THEY WERE NO LONGER GETTING AN EOS ON THE PP. IT WAS UNKNOWN HOW MANY TIMES THE PATIENT HAD GONE INTO OVERDISCHARGE. THE PATIENT WAS GOING TO FOLLOW-UP WITH HER HEALTHCARE PROVIDER (HCP). IN 2011 A MANUFACTURING REPRESENTATIVE TRIED TO CHARGE IT BUT WAS UNSUCCESSFUL. THEY TRIED TO GET IT GOING AGAIN IN 2011, BUT COULDN¿T. IN 2014, IT WAS NOTED THAT THE PATIENT DID NOT KNOW HOW TO GET A REPLACEMENT. SHE HAD NOT FELT FOR THE PAST FEW YEARS THAT SHE WOULD BE UP FOR THE REPLACEMENT SURGERY, BUT SHE WAS TAKING SO MUCH MEDICATION THAT ¿I JUST HAVE TO GO THROUGH WITH IT.¿ NO OUTCOME WAS 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804231 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1