BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 4110370 · Received September 23, 2014

    Report

    Report Number
    3004209178-2014-17531
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Report Date
    September 15, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION; PRODUCT ID 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION; PRODUCT ID 3998, LOT# L71784, IMPLANTED: (B)(6) 2000, 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 REPORTED THAT A PATIENT WAS CHARGING MORE THAN EXPECTED. IT WAS STATED THAT THE ESTIMATED RECHARGE INTERVAL WAS CALCULATED ON A LONGEVITY CALCULATOR. IT WAS STATED THAT SINCE THE NEW IMPLANT OF THE 37714 THE PATIENT FELT SHE WAS CHARGING MORE THAN SHE DID WITH HER PREVIOUS 37711. IT WAS NOTED THAT THEY DID NOT HAVE THE 37711 SETTINGS BUT THE 37714 SETTINGS WERE 420PW/R60/3.5-5V/THREE POSITIVE CONTACTS AND ONE NEGATIVE AND THE PATIENT USED STIMULATION ABOUT 12 HOURS DAY. IT WAS NOTED THAT TROUBLESHOOTING ACTION ITEMS WERE DISCUSSED. IT WAS STATED THAT NO SERIOUS ISSUES WERE OBSERVED BUT NORMAL BEHAVIOR AND EDUCATION WERE NEEDED. ON (B)(6) 2014 THE PATIENT MET WITH A COMPANY REPRESENTATIVE, AS SHE WAS STILL UNHAPPY WITH THE RECHARGE INTERVAL FROM THE NEW (SMALLER) STIMULATOR (INS). THE INS WAS INTERROGATED AND IT WAS NOTED THE PATIENT HAD BEEN CHARGING EVERY 2.8 DAYS FOR 1 HOUR. THE PATIENT HAD CHARGED 10 TIMES SINCE THE LAST INTERROGATION IN AUGUST. WHEN THE PATIENT CHARGED EVERY 3 DAYS, SHE WOULD CHARGE TO 50-75%. SHE HAD FULL COUPLING ON AVERAGE. THE COMPANY REPRESENTATIVE DECREASED HER PARAMETERS TO SEE IF THAT HELPED HER INTERVAL. THE PATIENT WAS COMFORTABLE WITH STIMULATION. THE PATIENT ALSO REPORTED THAT 3-4 TIMES SINCE (B)(6) 2014, THE STIMULATION WOULD BE ON BUT WOULD TURN OFF COMPLETELY. THE PATIENT WOULD HAVE PAIN DOWN HER LEGS. IT WAS REVIEWED THAT THE PATIENT NEEDED THE PROGRAMMER TO SYNC AT THESE TIMES, IN ORDER TO MAKE SURE THE LIGHTNING BOLT WAS TRULY OFF. ADDITIONAL INFORMATION WAS REQUESTED REGARDING THE RECHARGE INTERVAL AND THE LOSS OF STIMULATION ISSUES. IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS FURTHER STATED THAT A COMPANY REPRESENTATIVE HAD NOT SEEN THE PATIENT SINCE (B)(6) 2014. IT WAS BELIEVED THAT AFTER CALLING CUSTOMER SERVICE THAT THE DEVICE MAY HAVE BEEN ON BUT NEEDED AN AMPLITUDE INCREASE. THERE WERE NO UPDATES TO THE RECHARGING FREQUENCY. THE PULSEWIDTH AND ELECTRODES WERE CHARGING TO REFLECT THE LOWEST POSSIBLE POWER OUTPUT. THE PATIENTS STATUS WAS UNKNOWN AS OF (B)(6) 2014 AND THERE WERE NO FUTURE APPOINTMENTS SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591991 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 00065 YR