BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 3848954 · Received June 4, 2014

    Report

    Report Number
    3004209178-2014-10118
    Event Type
    Malfunction
    Date Received
    June 4, 2014
    Report Date
    May 13, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 377860, LOT# V004741, IMPLANTED: 2006-(B)(4), PRODUCT TYPE LEAD. PRODUCT ID 377860, LOT# V003916, IMPLANTED: 2006-(B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REPLACEMENT SURGERY WAS SCHEDULED FOR MONDAY. IT WAS NOTED THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS BEING REPLACED DUE TO NORMAL BATTERY DEPLETION. IT WAS FURTHER NOTED THE MANUFACTURING REPRESENTATIVE WANTED TO KNOW HOW THEY COULD TEST THE LEADS. THE REPORTER STATED THE PATIENT HAD LET THEIR INS GO AND THE INS WAS OVERDISCHARGED. THE REPORTER FURTHER STATED THEY DID NOT KNOW THE SPECIFICS SURROUNDING THE OVERDISCHARGE. IT WAS NOTED THE MANUFACTURING REPRESENTATIVE DID NOT THINK THERE WAS A PROBLEM WITH THE LEADS. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS DOING WELL. IT WAS NOTED THE PATIENT HAD THEIR INS REPLACED YESTERDAY DUE TO THE INS COMING UP ON END OF LIFE (EOL). IT WAS FURTHER NOTED THAT AN IMPEDANCE CHECK WAS DONE. THE REPORTER STATED THE PATIENT WAS PROGRAMMED AND ALL WAS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327088 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR