BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 4093410 · Received September 16, 2014

    Report

    Report Number
    3004209178-2014-17115
    Event Type
    Injury
    Date Received
    September 16, 2014
    Report Date
    August 22, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37092, LOT# 288330001, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: ACCESSORY; PRODUCT ID 3 7754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 39286-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SINCE TWO-3 WEEKS AGO A PATIENT HAD A WARM SENSATION AND PAIN IN OR AROUND/BEHIND THE IMPLANTABLE NEUROSTIMULATOR (INS) POCKET DURING RECHARGING. THE CALLER STATED THAT THE IMPLANTABLE NEUROSTIMULATOR RECHARGER (INSR) AND INS HEATED UP AND IT FELT ¿LIKE BURNING.¿ IT WAS REPORTED THAT THERE WAS LOSS OF COMMUNICATION AND THE CALLER REPORTED SEEING THE ¿THERMOMETER SCREEN¿ ONE TIME. IT WAS STATED THAT LAST NIGHT THE CALLER STOPPED RECHARGING AT 3/4 FULL BATTERY WHEN THE INS BEGAN BURNING. IT WAS STATED THAT THE CALLER MET WITH A MANUFACTURER¿S REPRESENTATIVE WHO CHECKED AND SAID THE INS BATTERY WAS FULL. IT WAS NOTED THAT MANUFACTURER¿S REPRESENTATIVE SUSPECTED OVERCHARGING. IT WAS STATED THAT THE INS WAS DETERMINED NOT TO BE THE ISSUE, AND THE MANUFACTURER¿S REPRESENTATIVE THOUGHT THAT THE POSSIBLE OVERCHARGING WAS CAUSING THE BURNING/PAIN. ADDITIONAL INFORMATION REPORTED THAT THE MANUFACTURER¿S REPRESENTATIVE THOUGHT THERAPY WAS EFFECTIVE BUT RECHARGING WAS DIFFICULT. IT WAS STATED THAT THE MANUFACTURER¿S REPRESENTATIVE AND HEALTHCARE PROFESSIONAL (HCP/PHYSICIAN¿S ASSISTANT) FELT THE ¿CULPRIT¿ WAS THE RECHARGER. IT WAS STATED THAT REPAIRS WOULD SEND THE PATIENT A NEW ANTENNA AND AN UPDATE WOULD BE EXPECTED IF THE ISSUE DIDN¿T RESOLVE. IT WAS NOTED THAT THE PATIENT HAD AN APPOINTMENT ON 9/16. IT WAS NOTED THAT REPROGRAMMING, TROUBLESHOOTING, OR INTERVENTIONS WERE NOT NEEDED. THE RECHARGE ANTENNA WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS AND IT WAS STATED THAT THE DEVICE TESTED TO SPECIFICATIONS AND THE COMPLAINT WAS NOT VERIFIED. IT WAS NOTED THAT IT HAD INITIALLY BEEN RECORDED AS C300 BUT WAS DETERMINED TO BE C100.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED STATED THAT THE PATIENT DID NOT REQUIRE THE MANUFACTURER'S REPRESENTATIVE (REP) AT HIS APPOINTMENT ON (B)(6) 2014 BECAUSE HIS ISSUES HAD RESOLVED.

    Description of Event or Problem · 1

    TWO WEEKS LATER IT WAS REPORTED THAT THE PATIENT WAS GOING TO HAVE A REVISION SURGERY. THEY WERE GOING TO MOVE THE INS FROM THE RIGHT BUTTOCK TO THE RIGHT ABDOMEN BECAUSE OF UNCOMFORTABLE BATTERY POSITION. THE PATIENT RECOGNIZED THE PAIN ABOUT THREE MONTHS AGO. THE CAUSE OF THIS EVENT WAS NOT DETERMINED. THE INS WAS REPOSITIONED ON (B)(6). REPROGRAMMING WAS NOT NEEDED. NO TROUBLESHOOTING OR OTHER ACTIONS WERE NEEDED. THE PATIENT WAS RECEIVING EFFECTIVE THERAPY AND HAS A POST-OP VISIT ON (B)(6).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS DOING WELL AND RECEIVING EFFECTIVE THERAPY WHEN HE WAS SEEN AT HIS APPOINTMENT ON (B)(6) 2014. THE MANUFACTURER'S REPRESENTATIVE (REP) HAD NOT HEARD FROM HIM SINCE THEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571809 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 00051 YR Required Intervention