BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 2972445 · Received February 21, 2013

    Report

    Report Number
    3004209178-2013-02954
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Report Date
    December 2, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) (SERIAL NUMBER: (B)(4)) FOUND DEVICE WAS USING A KNOWN GOOD AAQ 8870 CARD; MESSAGE 27 APPEARED ON THE 8840, "DETECTED DEVICE NOT SUPPORTED BY THIS VERSION OF APPLICATION CARD. CONTACT MEDTRONIC TECHNICAL SERVICE" THIS MESSAGE CONFIRMS THERE WAS AN INCOMPLETE WRITE OF THE INS EEPROM 1K BLOCK DURING THE INITIAL 8840 SESSION. THE 8840 APPLICATION DOES NOT CORRECTLY HANDLE INTERROGATION OF A DEVICE WITH PARTIALLY WRITTEN DATA IN THE 1K BLOCK. A 1K BLOCK FIX WAS PERFORMED PER (B)(4). AFTER THE 1K BLOCK FIX THE INS PASSED ALL FUNCTIONAL TESTS. ANALYSIS OF THE WRENCH ACCESSORY FOUND NO ANOMALY.

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_WRENCH_ACC, PRODUCT TYPE ACCESSORY. (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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE A BATTERY WAS INTERROGATED. THE CLINICIAN PROGRAMMER SCREEN SHOWED 100% BATTERY LIFE, HOWEVER THE TELEMETRY COULD NOT BE COMPLETED. IT WAS STATED THAT THE BATTERY WAS NO GOOD. NO PATIENT DEATH OR INJURY WAS REPORTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76494 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