BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3882238 · Received June 18, 2014

    Report

    Report Number
    3004209178-2014-11784
    Event Type
    Injury
    Date Received
    June 18, 2014
    Report Date
    June 13, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37751, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 355538, LOT# N407633, PRODUCT TYPE: ACCESSORY; PRODUCT ID 39286-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD; PRODUCT ID 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS NOTED THERE WERE NO ISSUES FOUND WITH THE RECHARGER DURING BENCH TESTING, CHARGING INS, CHARGING RECHARGER, OR COMMUNICATIONS. IT WAS REPORTED THE ANTENNA WAS REPLACED DUE TO CABLE DISCOLORING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MANUFACTURER REPRESENTATIVE HAD MET WITH THE PATIENT ON THE DAY OF THIS REPORT. IT WAS NOTED THAT THE PATIENT¿S DEVICE COULD NOT BE RECHARGED. IT WAS STATED THAT THERE WAS A COUPLING ISSUE WHICH HAD BEEN OCCURRING SINCE THE DEVICE WAS IMPLANTED. IT WAS NOTED THAT THE PATIENT COULD ONLY GET 1 COUPLING BAR SHADED AND IT WAS STATED THAT THE 1 COUPLING BAR OCCURRED ¿ONLY SOMETIMES.¿ IT WAS STATED THAT THE PATIENT HAD NEVER BEEN ABLE TO FULLY RECHARGE HER IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS NOTED THAT THE MANUFACTURER REPRESENTATIVE WAS NOT ABLE TO INTERROGATE THE PATIENT¿S DEVICE. IT WAS NOTED THAT THE PATIENT¿S POCKET SITE HAD ALWAYS BEEN LOOSE AND SHE COULD ¿EASILY GRASP THE INS.¿ IT WAS STATED THAT THE PATIENT HAD X-RAYS TAKEN ON THE DAY OF THIS REPORT AND WAS TOLD THAT EVERYTHING LOOKED FINE. IT WAS STATED THAT THE PATIENT FELT A WARM SENSATION IN OR AROUND THE INS POCKET WHILE SHE WOULD CHARGE THE INS. IT WAS NOTED THAT THE WARMING ISSUE HAD BEEN OCCURRING SINCE THE DEVICE WAS IMPLANTED. IT WAS NOTED THAT THE PATIENT HAD NEVER RECEIVED THE ¿TEMPERATURE SCREEN.¿ IT WAS STATED THAT THE INS HAD BEEN IN AN OVERDISCHARGE STATE. IT WAS NOTED THAT A PHYSICIAN MODE RECHARGE (PMR) WAS PERFORMED AND THE REP WAS ABLE TO CONNECT TO THE INS. IT WAS FURTHER NOTED THAT ¿AFTER A WHILE¿ A 6 COUPLING BAR CONNECTION WAS ACHIEVED; HOWEVER, AFTER 60 SECONDS THE STRENGTH WOULD GO TO ZERO BARS AND WOULD CONTINUOUSLY DO SO. IT WAS STATED THAT IT WAS NOT POSSIBLE TO CLEAR A POWER ON RESET (POR), THOUGH IT WAS NOTED THAT NO POR EVER APPEARED. IT WAS NOTED THAT AFTER USING THE ANTENNA LOCATE (AL) FEATURE, THE RECHARGING STRENGTH ISSUES CONTINUED. IT WAS NOTED THAT THE INS POCKET SITE WAS ¿STABLE.¿ IT WAS NOTED THAT THERE WEREN¿T ANY SPARE RECHARGERS TO TRY. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE ANOMALY APPEARED TO HAVE OCCURRED THROUGH PRODUCT USED AND THERE WAS NO INDICATION OF PATIENT HARM.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S STIMULATOR WAS STARTED UP. IT WAS NOTED THE PATIENT HAD GOOD COVERAGE ACROSS THEIR LOW BACK AND LEGS.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE ENTIRE SYSTEM WAS REPLACED DURING A LEAD REVISION. IT WAS NOTED, THE START-UP APPOINTMENT WAS SCHEDULED FOR 2014 (B)(6).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD STILL BEEN SORE AS OF (B)(6) AND HAD NOT BEEN READY TO "START UP." IT WAS NOTED THAT THE PATIENT WOULD CALL A MANUFACTURER REPRESENTATIVE WHEN READY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358848 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 00049 YR Required Intervention