BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3071632 · Received April 22, 2013

    Report

    Report Number
    3004209178-2013-06691
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    April 10, 2013
    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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3778-60 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3778-60 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3778-60 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (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. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STIMULATOR WAS IMPLANTED IN 2010 AND THEN QUIT WORKING AFTER A COUPLE OF MONTHS. IT WAS REPORTED THAT THE LEADS HAD COME LOOSE AND WERE LYING IN THE BOTTOM OF THE SPINAL COLUMN. THE PATIENT HAD A WORKMAN'S COMPENSATION ORDER TO HAVE THE LEADS REATTACHED. IMAGING WAS PERFORMED IN (B)(6) 2013 AND THE PATIENT WAS SCHEDULED FOR SURGERY FOR (B)(6) 2013. IT WAS NOTED THAT THE INS WAS OVERDISCHARGED AND THE HCP AND MANUFACTURER REPRESENTATIVE WOULD NEED TO GET THE INS GOING AGAIN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT HAD NOT RECHARGED THE IMPLANTABLE NEUROSTIMULATOR (INS) FOR "A FEW MONTHS" WHEN THE INS "QUIT WORKING". IT WAS NOTED THAT THE PATIENT COULD NOT GET THE INS TO "TAKE A CHARGE". IT WAS REPORTED THAT THE LEADS WERE 3 OR 4 INCHES AWAY FROM WHERE THEY "SHOULD HAVE BEEN ATTACHED" AND WERE LAYING DOWN IN "THE VERY BOTTOM" OF THE PATIENT'S SPINAL COLUMN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171437 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 Required Intervention