BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 5088763 · Received September 18, 2015

    Report

    Report Number
    3004209178-2015-18283
    Event Type
    Injury
    Date Received
    September 18, 2015
    Report Date
    August 25, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3986A60, LOT# N197226, IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3986A60, LOT# N192621, IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3986A60, LOT# N197226, IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3986A60, LOT# N192621, IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4)

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM A CONSUMER REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE INDICATION FOR USE INCLUDED OCCIPITAL NEURALGIA AND SPINAL PAIN. THE PATIENT REPORTED THAT IN 2013 THEY DEVELOPED A STAPH INFECTION IN THE BACK OF THEIR HEAD AFTER A LEAD REVISION. THE SYSTEM WAS EXPLANTED AND REPLACED AFTER THAT. SEE MANUFACTURER REPORT NUMBER 3004209178-2013-12240 FOR INFORMATION REGARDING THE LEAD REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618522 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 00051 YR Required Intervention