BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 3998900 · Received August 11, 2014

    Report

    Report Number
    3004209178-2014-15076
    Event Type
    Injury
    Date Received
    August 11, 2014
    Date of Event
    December 16, 2005
    Report Date
    July 14, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 355029, LOT# N0051184, IMPLANTED: 2005 (B)(6); PRODUCT TYPE ACCESSORY PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: 2005 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 377645, LOT# V001341, IMPLANTED: 2005 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: 2005 (B)(6); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: 2005 (B)(6); PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING THE PATIENT¿S IMPLANT SURGERY, THE HEALTH CARE PROVIDER (HCP) BUMPED THE TABLE AND THE PATIENT FELL ON THE GROUND. AS A RESULT THE PATIENT¿S SHOULD WAS ¿TORE UP¿ AND THEY HAD TO HAVE A SHOULDER REPLACEMENT SURGERY. INFORMATION OMITTED PERTAINING TO ERI AS IT IS NOT A COMPLAINT. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED, THE CAUSE OF THE EVENT WAS DETERMINED AND IT WAS NOT DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475422 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Required Intervention