BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 4910509 · Received July 13, 2015

    Report

    Report Number
    3004209178-2015-13276
    Event Type
    Injury
    Date Received
    July 13, 2015
    Date of Event
    August 8, 2013
    Report Date
    June 22, 2015
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: RECHARGER. PRODUCT ID: 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD AN ACCIDENT IN (B)(6) 2013, THE PATIENT HAD A FALL AND IT WAS UNKNOWN IF THE PATIENT WAS HAVING ISSUES. IT WAS NOTED THAT ISSUE WITH THE IMPLANTABLE NEUROSTIMULATOR WAS UNKNOWN. FOLLOW UP REPORTED THAT THE PATIENT HAD A MOTOR VEHICLE ACCIDENT IN (B)(6) 2014. REPROGRAMMING WAS ATTEMPTED BUT UNSUCCESSFUL . THE CAUSE OF THE EVENT WAS NOT DETERMINED AND IT WAS UNKNOWN IF THE ISSUE WAS RELATED TO THE DEVICE. THE PATIENT HAD THE DEVICE EXPLANTED (B)(6) 2014 AND RECOVERED WITHOUT PERMANENT IMPAIRMENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW UP REPORT WILL BE SENT OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451852 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 00028 YR Required Intervention