BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 1910638 · Received November 19, 2010

    Report

    Report Number
    3004209178-2010-09831
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    April 13, 2006
    Report Date
    November 15, 2010
    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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 377760, LOT# N0047809, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID 377760, LOT# N0047809, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: PROGRAMMER, PATIENT.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 377760, LOT# N0047809, IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 377760, LOT# N0047809, IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THE PT'S STIMULATOR WAS NOT HELPING. THE PT WOULD TURN THE STIMULATION UP BUT IT WAS MORE PAINFUL. THE DEVICE WAS REPROGRAMMED A COUPLE OF TIMES WITHOUT SUCCESS. ADDITIONAL INFO RECEIVED INDICATED THE PT'S LOSS OF PAIN COVERAGE WAS DUE TO LEAD MIGRATION/DISLODGEMENT. AN INABILITY TO PROGRAM WITH IMPEDANCE VALUES <4000 OHMS WERE NOTED ON (B)(6) 2006. BOTH LEADS WERE REPLACED TEN DAYS LATER. THE PT WAS NOTED TO HAVE RESOLVED WITHOUT SEQUELA BY (B)(6) 2006.

    Description of Event or Problem · 1

    .

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention EXPLANTED:| LEAD: MODEL 3777, LOT# N0047809| IMPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD013366N| EXPLANTED:| LEAD: MODEL 3777, LOT# N0047809| IMPLANTED: