BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 3071335 · Received April 22, 2013

    Report

    Report Number
    3004209178-2013-06673
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    April 5, 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
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 377745, LOT# N0030362, IMPLANTED: (B)(6) 2005, PRODUCT TYPE LEAD; PRODUCT ID 377745, LOT# N0042225, IMPLANTED: (B)(6) 2005, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE RECHARGER; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE EXTENSION; PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 37711, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3888-33, LOT# V042634, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 3888-33, LOT# V042634, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 37742, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37711, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2009, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3888-45, LOT# V042640, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 3888-45, LOT# V042640, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE LEAD PROTRUDED THROUGH THE SKIN. IT WAS NOTED THE INS WAS REMOVED ON (B)(6) 2011 AND THE LEAD WAS REMOVED ON (B)(6) 2011. IT WAS FURTHER NOTED THE INS AND LEAD WERE NOT REPLACED. IT WAS NOTED THE PATIENT FULLY RECOVERED. SEE MFR. REPORTS #3004209178-2013-06674 AND #3004209178-2013-06675. IT WAS UNCLEAR WHICH DEVICE WAS REMOVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD AN IMPLANTABLE NEUROSTIMULATOR (INS) PLACED WRONG, ON THE PATIENT'S RIGHT INSTEAD OF LEFT LEG, WHICH REQUIRED A SECOND SURGERY TO REPOSITION THE DEVICE. IT WAS ALSO REPORTED THE PATIENT HAD NUMBNESS DOWN THEIR LEFT LEG, WHICH IS WHY THE HEALTHCARE PROVIDER HAD TO REPOSITION THE DEVICE. IT WAS ALSO NOTED THE PATIENT HAD THREE DEVICES IMPLANTED AND IT WAS UNKNOWN WHICH DEVICE THE PATIENT WAS REFERENCING.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE HEALTHCARE PROVIDER (HCP) HAD PUT THE LEAD THAT WAS "STUCK OUT OF THE BODY" BACK IN PRIOR TO REMOVING IT A WEEK LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172224 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention