BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 3113822 · Received May 15, 2013

    Report

    Report Number
    3004209178-2013-07707
    Event Type
    Injury
    Date Received
    May 15, 2013
    Report Date
    April 29, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3550-02, LOT# N268662, IMPLANTED: (B)(6) 2011. PRODUCT TYPE: ACCESSORY: PRODUCT ID 365538, LOT# N293848, IMPLANTED: (B)(6) 2011. PRODUCT TYPE: ACCESSORY: PRODUCT ID 355531, LOT# N294340, IMPLANTED: (B)(6) 2011. PRODUCT TYPE: SCREENING DEVICE: PRODUCT ID 37752, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: EXTENSION: PRODUCT ID 377845, LOT# V001578, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2011. PRODUCT TYPE: LEAD: PRODUCT ID 37743, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 377845, LOT# V001578, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2011. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IT WAS DETERMINED THAT THE PATIENTS LEAD WIRES HAD BROKEN AND HAD CAUSED THE PATIENT PAIN. IT WAS NOTED THAT THIS WAS IN (B)(6) 2011. IT WAS NOTED THAT HER DOCTOR REPLACED THE ENTIRE SYSTEM. IT WAS FURTHER NOTED THAT THERE HAD BEEN NOT FALLS OR TRAUMA DURING THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215311 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