BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3030949 · Received April 2, 2013

    Report

    Report Number
    3004209178-2013-04477
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Report Date
    March 18, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37712 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 3777-60 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 3777-60 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 37743 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 37752 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID 37752 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID 3777-45 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 37743 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3777-45 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD BEEN CHARGING ISSUES FOR A WHILE. THE PATIENT STATED THAT SHE MET WITH A MANUFACTURER REPRESENTATIVE ON (B)(6) 2013 TO TRY A "TRICKLE CHARGE" BUT WAS UNSUCCESSFUL. THE PATIENT LATER TRIED TO CHARGE HER INS AND SAW A "CALL YOUR DOCTOR" ICON WITH AN END OF SERVICE (EOS) CODE. IT WAS NOTED THAT THE PATIENT HAD BEEN HOSPITALIZED 2-3 TIMES DUE TO HER MEDICAL ISSUES AND HAD BEEN UNABLE TO CHARGE. THE PATIENT HAD TWO NEUROSTIMULATORS AND IT WAS UNCLEAR WHICH INS THE CODE WAS SEEN ON, OR IF IT WAS SEEN ON BOTH. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. SEE ALSO MFR. REP. # 3004209178-2013-04476.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134612 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1