BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3160070 · Received June 10, 2013

    Report

    Report Number
    3004209178-2013-10050
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    November 1, 2012
    Report Date
    May 20, 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
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37743 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID: 3 778-60 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3776-75 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 37752 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD BROKE IN (B)(6) 2012 AND THE PATIENT WAS SCHEDULED TO GET A REPLACEMENT IN (B)(6) 2013, HOWEVER, HE SUFFERED A HEART ATTACK ON (B)(6) 2012 AND HAD A PACEMAKER IMPLANTED IN (B)(6) 2013. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259626 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 00055 YR Required Intervention