BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3062128 · Received April 16, 2013

    Report

    Report Number
    3004209178-2013-06394
    Event Type
    Injury
    Date Received
    April 16, 2013
    Report Date
    April 3, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 39565-65 LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD. ANALYSIS OF NEUROSTIMULATOR MODEL 37714 SERIAL # (B)(4), SHOWED NO ANOMALIES AND IT WAS OBSERVED THAT THE DEVICE IMPLANT LIFE HAD NOT BEEN STARTED. THE DEVICE WAS ABLE TO BE INTERROGATED WITH 2 CLINICIAN PROGRAMMER COMPONENTS WITH THE APPROPRIATE SOFTWARE CARDS (8870, VERSIONS AAQ AND AAK). IT WAS NOTED THAT EARLIER VERSIONS OF THE 8870 SOFTWARE CARD ARE NOT CAPABLE OF COMMUNICATING WITH THIS MODEL DEVICE. ANALYSIS OF LEAD MODEL 39565-65 SERIAL# (B)(4), SHOWED NO SIGNIFICANT ANOMALIES. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE BATTERY WAS IMPLANTED THE HCP HAD A LITTLE TROUBLE READING THE BATTERY. WHEN THE PATIENT HAD A FOLLOW-UP VISIT IT WAS DETERMINED THAT THE PATIENT HAD AN INFECTION AND THE IMPLANT WAS REMOVED. ONCE THE BATTERY WAS REMOVED IT HAD 75% BATTERY LIFE, AND THE BATTERY COULD NOT BE INTERROGATED ONCE IT WAS OUT OF THE PATIENT'S BODY. THREE DIFFERENT 8840 PROGRAMMERS WITH THE CORRECT SOFTWARE CARDS WERE TRIED AND THEY ALL SAID THEY COULD NOT READ THE BATTERY. IT WAS NOTED THAT THE PATIENT'S INFECTION TRACKED ALL THE WAY UP TO THE LEAD. IT WAS LATER REPORTED THAT A CULTURE WAS DRAWN AT THE TIME OF EXPLANT, BUT THE RESULTS WERE NOT AVAILABLE. THE PATIENT WAS RECOVERING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162185 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