BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1983046 · Received February 4, 2011

    Report

    Report Number
    9614453-2011-00891
    Event Type
    Injury
    Date Received
    February 4, 2011
    Date of Event
    March 25, 2010
    Report Date
    January 18, 2011
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE DEVICE DID NOT WORK SINCE. THERE WERE HIGH LEAD IMPEDANCES. ON (B)(6) 2010, SURGICAL INTERVENTION WAS DONE. THERE SEEMED TO ONLY BE A CONNECTION ISSUE. THE EXTENSION WAS MOVED FROM THE 0-7 PORT TO THE 8-15 PORT AS THIS WAS SEEN TO BE PART OF THE ISSUE. THE DEVICE WORKED WELL FOR THE PT FOR A COUPLE MONTHS UNTIL SHE HAD A FALL AND THE STIMULATION WAS NOT EFFECTIVE ANYMORE. SOME BENEFIT CAME FROM A FEW REPROGRAMMING SESSIONS. IN (B)(6) 2011, THE STIMULATION BECAME PAINFUL AND SHE WAS RECEIVING "STRANGE" MESSAGES (ONE WAS EOS) ON THE PT PROGRAMMER. UPON INTERROGATION, THE DEVICE SEEMED TO BE WORKING PROPERLY, BUT IMPEDANCES WERE HIGH. THE DECISION WAS MADE TO REPLACE THE LEADS. AN X-RAY CONFIRMED THAT ONE OF THE LEADS HAD MIGRATED AND POSSIBLY THE ENTIRE SYSTEM. THE LEADS WERE REPLACED AND CONNECTED TO THE EXTENSION AND INS, BUT IMPEDANCES WERE STILL HIGH. THE EXTENSION WAS THEN REPLACED, BUT WHEN RECONNECTING TO THE INS, IT REQUIRED A SIGNIFICANT AMOUNT OF FORCE TO REMOVE THE OLD EXTENSION FROM THE PORT. ONCE REMOVED, A SIGNIFICANT "CORROSION" WAS NOTED. IMPEDANCES WERE CHECKED IN THE OTHER PORT AND SHOWED A FEW HIGH VALUES, SO THE DECISION WAS MADE TO REPLACE THE INS AS WELL. WHEN THE NEW INS WAS CONNECTED, ALL IMPEDANCES WERE IN NORMAL RANGE. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED RECHARGEABLE LGW MEDTRONIC EUROPE SARL 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 37082, LOT# UNK| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 37082, LOT# NKB016818N| LEAD: MODEL 3093, LOT# 0202744158| LEAD: MODEL 3093, LOT# 0202735476| IMPLANTED: