BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3761695 · Received April 21, 2014

    Report

    Report Number
    3004209178-2014-07593
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Report Date
    March 31, 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: 377860, LOT# V019919, PRODUCT TYPE: LEAD. PRODUCT ID: 377860, LOT# V020196, PRODUCT TYPE: LEAD. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37742, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3708140, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708140, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A COMMUNICATION PROBLEM. AN IMPLANTABLE NEUROSTIMULATOR (INS) OVERDISCHARGE WAS SUSPECTED. THE LAST TIME THE PATIENT FELT STIMULATION WAS AROUND (B)(6) 2013. THEY ATTEMPTED TO USE STIMULATION IN (B)(6) BUT IT DIDN¿T WORK. IT WAS UNKNOWN WHEN THE LAST SUCCESSFUL RECHARGING SESSION WAS. IT WAS NOTED THAT A MANUFACTURER REPRESENTATIVE TRIED A PHYSICIAN MODE RECHARGE FOR 5 HOURS BUT THEY WERE UNABLE TO GET THE BATTERY TO WORK. A MANUFACTURER REPRESENTATIVE TRIED TO USE THE ANTENNA LOCATE FEATURE BUT THE PATIENT HAD AN OLDER RECHARGER THAT DID NOT SUPPORT THIS FUNCTION. IT WAS FURTHER REPORTED THAT AFTER THE PHYSICIAN MODE RECHARGE THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WAS DEAD. THE PATIENT HAD NOT USED THEIR DEVICE IN 1-2 YEARS. A MANUFACTURER REPRESENTATIVE PERFORMED A PHYSICIAN RECHARGE MODE (PRM) FOR 4-5 HOURS BUT WAS UNABLE TO ACTIVATE THE BATTERY. IT WAS NOTED THAT THE EVENT WAS A NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI). ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240801 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1