BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3100509 · Received May 8, 2013

    Report

    Report Number
    3004209178-2013-07398
    Event Type
    Injury
    Date Received
    May 8, 2013
    Report Date
    April 16, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 39286-65, SERIAL# (B)(4), IMPLANTED: 2012-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 37754, SERIAL# (B)(4), (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). NOTE: THIS ALLEGATION WAS PREVIOUSLY CAPTURED IN A RELATED EVENT (MFR REPORT 3004209178-2013-23899).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE ORIGINAL IMPLANTING HEALTHCARE PROVIDER (HCP) DID THE IMPLANT INCORRECTLY AND IT WAS NOT CONNECTING TO THE SPINAL COLUMN. THE PATIENT WAS UNABLE TO USE THE DEVICE UNTIL THE LEADS WERE REPOSITIONED IN MARCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S INITIAL IMPLANT DID NOT WORK BECAUSE THE LEAD WASN'T 'PLACED FORWARD.' IT WAS NOTED THAT THE PATIENT HAD A LEAD REVISION ON (B)(6)-2013. TWO DAYS LATER, IT WAS REPORTED THAT AFTER DEVICE IMPLANT, THE PATIENT WAS NOT USING STIMULATION AT ALL BECAUSE THE PATIENT WOULD NOT FEEL STIMULATION WHEN THE IMPLANTABLE NEUROSTIMULATOR WAS ON. IT WAS NOTED THAT THE LEAD WAS REVISED BECAUSE THE LEAD WAS 'NOT IN THE SPACE.' THE REPORTER NOTED THAT AN ADHESIVE WAS POSSIBLY USED DURING THE LEAD REVISION.

    Description of Event or Problem · 1

    PER PPS, ADDITIONAL CODING APPLIED BECAUSE THE FOLLOWING WAS INCLUDED IN THE EVENT DESCRIPTION: "PATIENT WAS NOT USING STIMULATION BECAUSE WHEN THE DEVICE WAS ON THE PATIENT WOULD NOT FEEL STIMULATION."

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED BEFORE THE LEAD REVISION, THE LEADS ¿DIDN¿T GO IN AND WERE NOT MAKING CONTACT¿, SO THE PATIENT WAS UNABLE TO USE THE DEVICE. IT WAS STATED THE ¿DOCTOR PUT THEM IN WRONG, SO THEY COULDN¿T USE IT.¿ IT WAS NOTED THEY ¿RELOCATED THE TERMINAL ENDS.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200270 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 00067 YR Required Intervention