BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 4739700 · Received April 30, 2015

    Report

    Report Number
    3004209178-2015-08200
    Event Type
    Injury
    Date Received
    April 30, 2015
    Report Date
    April 6, 2015
    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
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 377775, LOT # V004485, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 355029, LOT # N060883, IMPLANTED: (B)(6) 2006, PRODUCT TYPE ACCESSORY; PRODUCT ID 37742, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37752, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LEAD REVISION WHERE THE PATIENT WENT FROM A PERCUTANEOUS LEAD TO A SURGICAL LEAD. NO FURTHER INFORMATION WAS AVAILABLE REGARDING THE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285845 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