BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3183022 · Received June 21, 2013

    Report

    Report Number
    3004209178-2013-10732
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    May 30, 2013
    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 37714 RESTORE, SERIAL #(B)(4)) FOUND IT TO BE FUNCTIONALLY OKAY WITH INSIGNIFICANT ANOMALIES. SHIELD/CAN WAS DENTED. LEADS COULD BE FULLY INSERTED INTO BOTH PORTS.

    Additional Manufacturer Narrative · 1

    UPON FURTHER REVIEW, FDC CODE NO LONGER APPLIES TO EVENT, AND ADDITIONAL FDM CODE WAS ADDED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INS HAD NEVER BEEN IMPLANTED DUE TO CONTACTS 8-15 HAVING GREATER THAN 10000 OHMS IMPEDANCES. DURING THE PROCEDURE THE LEADS WERE WIPED DOWN MULTIPLE TIMES AND INSERTED INTO THE INS (IMPLANTABLE NEUROSTIMULATOR) BLOCKS THEN EACH LEAD WAS REVERSED AND INSERTED INTO THE BLOCKS. IT WAS STATED THAT CONTACTS 8-15 HAD OUT OF RANGE IMPEDANCES NO MATTER WHAT LEAD END WAS INSERTED. PATIENT STATUS AT TIME OF THIS REPORT WAS NOTED AS ALIVE WITH NO INJURY/NO ADVERSE EVENT. AS A RESULT, ANEW INS WAS OPENED AND IMPLANTED. THERE WERE NO PATIENT SYMPTOMS/INJURIES RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282476 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 00076 YR