BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 4338543 · Received December 17, 2014

    Report

    Report Number
    3004209178-2014-24178
    Event Type
    Injury
    Date Received
    December 17, 2014
    Report Date
    December 2, 2014
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 377875, LOT# V001924, IMPLANTED: 2006 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 377860 LOT# V002517, IMPLANTED: 2006 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 7495-51, SERIAL# (B)(4), IMPLANTED: 1996 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 37754, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS DOING GREAT AND BENEFITING FROM THEIR DEVICE AND ADAPTIVE STIMULATION. ALL ISSUES WERE RESOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED, THERE WAS STIMULATION IN THE WRONG LOCATION WHEN STIMULATION WAS ON, WHICH BEGAN ONE WEEK AGO. THE LOCATION BEING THE IMPLANTABLE NEUROSTIMULATOR (INS) POCKET. AS A RESULT, THE PATIENT EXPERIENCED PAIN AND COULD NOT USE THE DEVICE FOR LONG PERIODS OF TIME. IMPEDANCE TESTING AND REPROGRAMMING WERE PERFORMED. THE INS WAS EXPLANTED AND REPLACED. THE PATIENT STATUS WAS ALIVE WITH NO INJURY AND WAS DOING WELL POST-REVISION. A POST-OPERATION FOLLOW-UP MEETING WAS SCHEDULED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829022 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 00051 YR Required Intervention