BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 3881957 · Received June 18, 2014

    Report

    Report Number
    3004209178-2014-11776
    Event Type
    Injury
    Date Received
    June 18, 2014
    Report Date
    May 30, 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_RECHARGER_ACC, SERIAL# UNKNOWN; PRODUCT TYPE RECHARGER PRODUCT ID 39565, SERIAL# UNKNOWN; PRODUCT TYPE LEAD PRODUCT ID NEU_UNKNOWN_EXT, SERIAL# UNKNOWN; PRODUCT TYPE EXTENSION PRODUCT ID NEU_UNKNOWN_EXT, SERIAL# UNKNOWN; PRODUCT TYPE EXTENSION PRODUCT ID NEU_PTM_PROG, SERIAL# UNKNOWN; PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID NEU_UNKNOWN_EXT, SERIAL# UNKNOWN; PRODUCT TYPE EXTENSION PRODUCT ID NEU_UNKNOWN_EXT, SERIAL# UNKNOWN; PRODUCT TYPE EXTENSION (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE STIMULATION FELT ON THE PATIENT¿S TYPICAL PROGRAM CHANGED. IT WAS NOTED THE IMPEDANCE ON ELECTRODE FOURTEEN WAS GREATER THAN 3,600 OHMS. IT WAS REPORTED THE STIMULATOR WAS GETTING HOT DURING RECHARGE AND CAUSED PAIN. IT WAS NOTED THE ISSUES STARTED A MONTH PRIOR TO CALL. IT WAS FURTHER NOTED THE PATIENT HAD LOST SIXTY POUNDS OVER THE LAST YEAR. IT WAS REPORTED THE LEAD AND EXTENSION CONNECTION SITE SOMETIMES SWELLED UP DURING RECHARGE. IT WAS NOTED THE PATIENT DID NOT SEE A WARNING AND RECHARGING DID NOT STOP. IT WAS REPORTED THE HEATING HAPPENED AFTER TEN TO FIFTEEN MINUTES. IT WAS NOTED THE PATIENT COULD NOT FULLY CHARGE BECAUSE OF THE HEATING. IT WAS REPORTED THE ANTENNA DID NOT GET HOT. IT WAS NOTED TRYING A DIFFERENT RECHARGER DID NOT RESOLVE THE ISSUE. IT WAS REPORTED THE PATIENT HAD THEIR SYSTEM REPLACED. IT WAS REPORTED THE SYSTEM WAS REPLACED DUE TO PAIN AT THE ANCHOR SITES, EXTENSION CONNECTION SITES, AND THE BATTERY SITE. IT WAS NOTED THE CAUSE OF THE EVENT WAS WEIGHT LOSS. IT WAS REPORTED THE PATIENT HAD RELIEF BOTH PRIOR TO AND AFTER SURGERY. IT WAS NOTED THE LEAD WAS CUT SEVERAL TIMES DURING THE REMOVAL AND THERE WERE NO PROBLEMS WITH THE BATTERY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICES THEMSELVES WERE WORKING JUST FINE, HOWEVER THE SIZE OF THE BATTERY WAS THE ISSUE AS WELL AS THE CONNECTIONS WERE PAINFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357261 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00040 YR Required Intervention