BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2955097 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-02502
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Report Date
    January 22, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37752 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID: 37743 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID: 3708220 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID: 3708220 LOT#, (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID: 3487A-56 LOT# V260569, IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3487A-56 LOT# V375105, IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3487A-56 LOT# V167854, IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3487A-56 LOT# V346075, IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE PATIENT OUTCOME WAS NOTED, AS OF (B)(6) 2013, AS RESOLVED WITHOUT SEQUELAE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS NOT ABLE TO FULLY CHARGE HIS DEVICE. THE ISSUE WAS DIAGNOSED THROUGH DEVICE INTERROGATION ON (B)(6) 2013. THE REPORTER STATED THAT CHARGING ANALYSIS WAS PERFORMED ON THE DEVICE ON (B)(6) 2013. IT WAS UNCLEAR WHAT THIS REFERRED TO. IT WAS NOTED THAT THE LAST DEVICE PROGRAMMING OCCURRED ON (B)(6) 2012. IT WAS REPORTED THAT THERE WAS AN INABILITY TO CHARGE THE DEVICE DESPITE GOOD CONNECTION STATUS TO THE RECHARGER, AND THE ISSUE WAS RELATED TO THE DEVICE OR THERAPY BUT WAS UNLIKELY RELATED TO THE IMPLANT PROCEDURE. IT WAS NOTED THAT THERE WERE NO SIGNS OR SYMPTOMS RELATED TO THE EVENT. THE EVENT OUTCOME WAS NOTED AS "ONGOING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58642 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 00050 YR