BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2852998 · Received November 30, 2012

    Report

    Report Number
    3004209178-2012-10986
    Event Type
    Injury
    Date Received
    November 30, 2012
    Report Date
    November 5, 2012
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 39565-65 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37752 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID, 37743 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DEVICE WAS EXPLANTED. THE REPORTER STATED THAT THE DEVICE WAS FLIPPED, BUT IT WAS NOT CONFIRMED. IT WAS NOTED THAT OVERDISCHARGE WAS SUSPECTED. IT WAS REPORTED THAT THE STIMULATION IRRITATED THE PATIENT'S IRRITABLE BOWEL SYNDROME. THE REPORTER STATED THAT THE PATIENT HAD NO INJURY OR ADVERSE EVENT. IT WAS NOTED THAT ACTIONS REQUIRED AS A RESULT OF THE EVENT WERE LISTED AS CAPPED/ABANDONED/PARTIALLY REMOVED. IT WAS UNCLEAR IF PART OR ALL OF THE DEVICE SYSTEM WAS REMOVED. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT IT WAS UNKNOWN WHAT WAS CAPPED, ABANDONED, OR PARTIALLY REMOVED. IT WAS STATED THAT THE SURGEON'¿S PLAN WAS TO "SIMPLY DETACH THE LEADS AND BURY THEM IN THE EXISTING DEVICE POCKET AND REMOVE THE STIMULATION". NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention