BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3051435 · Received April 10, 2013

    Report

    Report Number
    3004209178-2013-05952
    Event Type
    Injury
    Date Received
    April 10, 2013
    Report Date
    March 28, 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
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 39565-65, SERIAL# (B)(40, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S LEAD MIGRATED UPWARD IN THE SPINE. THE HCP PULLED THE LEAD DOWN AND ATTEMPTED TO RE-ANCHOR IT ON A PREVIOUS DATE. THE PATIENT LATER RETURNED TO OFFICE AND REPORTED THAT STIMULATION WAS ONLY FELT IN THE ABDOMEN. THE HCP PLANNED TO X-RAY THE LEAD, AND IT WAS REPORTED THAT IT WAS SUSPECTED THAT THE LEAD HAD MIGRATED AGAIN AND THE SYSTEM WOULD HAVE TO BE REMOVED. IT WAS LATER REPORTED THAT THE SYSTEM WAS EXPLANTED. 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
    148447 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention