BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3173692 · Received June 17, 2013

    Report

    Report Number
    3004209178-2013-10473
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    June 10, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37744, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 37754, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD: PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF NEUROSTIMULATOR MODEL 37714 SERIAL # (B)(4) SHOWED NO ANOMALIES. ANALYSIS OF LEAD MODEL 3778-45 LOT # V884738007 SHOWED NO ANOMALIES. ANALYSIS OF LEAD MODEL 3778-45 LOT # V707985023 SHOWED NO ANOMALIES.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT A ¿STRANGE ICON¿ WAS SEEN ON THE PROGRAMMER UNIT WHEN TRYING TO COMMUNICATE WITH THE IMPLANTABLE NEUROSTIMULATOR (INS). THE MANUFACTURER¿S REPRESENTATIVE TRIED USING THEIR PROGRAMMER BUT GOT A ¿DEVICE NOT SUPPORT¿ MESSAGE. IT WAS DETERMINED THAT THEY HAD AN INCOMPATIBLE SOFTWARE VERSION ON THE PROGRAMMER FOR THE INS BEING INTERROGATED. IT WAS NOTED THAT THE THERAPY WAS WORKING FINE FOR THE PATIENT. FOLLOW UP INFORMATION RECEIVED ON (B)(4) 2012 DETERMINED THAT THE MESSAGE (ICON) THE PATIENT WAS SEEING WAS RELATED TO ¿ASKING WHERE HIS DEVICE WAS¿. THE PATIENT WAS RE-EDUCATED AND EXPRESSED THAT THEY UNDERSTOOD THE USE OF THE DEVICE. ON (B)(4) 2013 ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT¿S INS AND LEAD COMPONENTS WERE EXPLANTED WITH NO ALLEGATION OF A MALFUNCTION OR INJURY. FOLLOW UP INFORMATION RECEIVED ON (B)(4) 2013 REPORTED THAT THE REASON FOR THE DEVICE EXPLANTATION WAS THAT THE INS ORIGINALLY CONTROLLED THEIR SYMPTOMS BUT THEY EVENTUALLY LOST RELIEF FOR THEIR PAIN, POSSIBLY SECONDARY TO THE PATIENT'S DECREASING MEMORY AND COGNITIVE DIFFICULTIES. IT WAS ALSO REPORTED THAT THE PATIENT DESIRED TO HAVE AN MRI. THE PATIENT DID NOT HAVE THE INS REPLACED AND THEY WERE REPORTED AS DOING WELL PER THEIR POST EVALUATION AND WAS TO BE FOLLOWED AS NEEDED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274500 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention