BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2994193 · Received March 8, 2013

    Report

    Report Number
    3004209178-2013-03475
    Event Type
    Injury
    Date Received
    March 8, 2013
    Report Date
    February 22, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    A 3778-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. A 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. A 3778, LOT# V790896034, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. A 3778, LOT# V127462035, IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. A 3550-39 LOT# N213355, IMPLANTED: (B)(6) 2009-, PRODUCT TYPE: ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    LEAD 3778-60, SERIAL# (B)(4), IMPLANTED: 2011-(B)(6), EXPLANTED: 2013-(B)(6), LEAD 3778-75, SERIAL# (B)(4), IMPLANTED: 2009-(B)(6), EXPLANTED: 2013-(B)(6).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE SYSTEM WAS EXPLANTED. IT WAS UNCLEAR IF ALL PARTS OF THE SYSTEM WERE EXPLANTED AT THE SAME TIME.

    Description of Event or Problem · 1

    THE PATIENT WAS SCHEDULED FOR A REVISION ON (B)(6) 2013. THE REASON FOR THE REVISION WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    THE LEADS AND EXTENSIONS WERE REMOVED AND THE INS REMAINED IMPLANTED. THE DOCTOR LEFT THE INS IMPLANTED IN CASE THE PATIENT WANTED TO HAVE THE LEADS REPLACED IN THE FUTURE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD NOT BEEN BACK TO THE OFFICE SINCE EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98946 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