BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 3182919 · Received June 21, 2013

    Report

    Report Number
    3004209178-2013-10724
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    June 3, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: LEAD: PRODUCT ID 377760, LOT# V004734, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2009. PRODUCT TYPE: LEAD: PRODUCT ID 377760, LOT# V006394, IMPLANTED: (B)(6) 2006, EXPLANTED: 2009. PRODUCT TYPE: LEAD: PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: RECHARGER: PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3487A-45, LOT# J0454529V, IMPLANTED: (B)(6) 2004. PRODUCT TYPE: LEAD: PRODUCT ID 3487A-45, LOT# J0454529V, IMPLANTED: (B)(6) 2004. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD ¿LEAD PROBLEMS.¿ IT WAS NOTED THE LEADS ¿JUST QUIT WORKING¿ AND WERE REPLACED. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284147 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