BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 3061478 · Received April 16, 2013

    Report

    Report Number
    3004209178-2013-06352
    Event Type
    Injury
    Date Received
    April 16, 2013
    Report Date
    April 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37752 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID: 3888-33 LOT# V080822, IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3888-33 LOT# V070165, IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3778-45 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3708260 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID: 37742 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID: 3708160 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    2013 (B)(4): IT WAS REPORTED THAT THE PATIENT HAD LOST 70 POUNDS AND HAD BEEN HAVING TROUBLE RECHARGING HIS DEVICE EVER SINCE. IT WAS NOTED THAT THE PATIENT HAD RECHARGED THE DEVICE ABOUT A WEEK PRIOR TO THE EVENT. IT WAS NOTED THAT THE PATIENT WAS "IN A LOT OF PAIN" BECAUSE THE PATIENT'S DEVICE WAS NOT ON. IT WAS NOTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) WAS "TURNED INSIDE HIS BODY." IT WAS NOTED THAT THE HEALTH CARE PROFESSIONAL (HCP) WAS GOING TO REVISE. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163585 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention