BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3841455 · Received May 30, 2014

    Report

    Report Number
    3004209178-2014-09940
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 12, 2014
    Report Date
    June 25, 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 97791, LOT# N449420, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: ACCESSORY; PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT WAS ABLE TO ACHIEVE COUPLING WITH THEIR RECHARGER. THE MANUFACTURER REPRESENTATIVE DID NOT DO AN ADDITIONAL IMPEDANCE CHECK BUT THE STIMULATION WAS WORKING PROPERLY WITH NO ISSUES. THEY WERE NOT USING ANY OF THE EFFECTED ISSUES. THE REPRESENTATIVE WAS UNABLE TO DETERMINE WHAT THE CAUSE OF THE OVER-IMPEDANCE WAS. THE PATIENT WAS RECEIVING ABOUT 25% PAIN RELIEF FROM THEIR STIMULATION. THE MANUFACTURER REPRESENTATIVE ADDED ADDITIONAL GROUPS AND ADDED PULSE WIDTH AND RATE FOR THE PATIENT TO ADJUST. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY WAS CHARGED FOR 30 MINUTES POST-OPERATIVE UNTIL THE PATIENT COMPLAINED OF TOO MUCH PAIN AT THE BATTERY SITE BUT THEY WERE ABLE TO CHECK IMPEDANCES. IT WAS NOTED THAT ELECTRODES 9, 10, AND 15 WERE ¿OVER-IMPEDANCE¿ AND THAT ALL OTHER ELECTRODES WERE WITHIN NORMAL LIMITS. IT WAS FURTHER REPORTED THAT THE PATIENT HAD A FOLLOW UP VISIT ON THE DAY FOLLOWING THE REPORT BUT AT THE TIME, THE PATIENT¿S BATTERY WOULD STILL BE DISCHARGED SO THEY WOULD NEED TO ADDRESS REPROGRAMMING AND IMPEDANCES AT THE PATIENT¿S NEXT APPOINTMENT. IT WAS FURTHER REPORTED THAT THE PATIENT SAW THE HEALTH CARE PROFESSIONAL EARLIER THAN SCHEDULED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318535 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 00030 YR