BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURA DR

    MDR report key: 3993472 · Received August 8, 2014

    Report

    Report Number
    9614453-2014-01900
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 16, 2014
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Removal / Correction Number
    Z-0115-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED A POWER ON RESET OCCURRED, AND THAT WIRELESS TELEMETRY WAS UNABLE TO BE ESTABLISHED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. THERE WERE MULTIPLE POWER ON RESETS (POR) OCCURRING ON (B)(6) 2014. FURTHER POWER ON RESET (POR) OCCURRED ON (B)(6) 2014.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED A POWER ON RESET OCCURRED. ANALYSIS OF THE DEVICE MEMORY INDICATED THAT WIRELESS TELEMETRY WAS UNABLE TO BE ESTABLISHED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. THIS EVENT OCCURRED OUTSIDE THE US AND PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION.  BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF THE PRODUCT, IT COULD NOT DETERMINE THIS DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION. PRODUCTS: 6942-65 LEAD IMPLANTED 2005 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CONTINUES TO PRESENT AFTER DEVICE ALERTS AND ELECTRICAL RESETS ARE OBSERVED. THE PATIENT'S FAMILY STATES THE RESETS COINCIDE WITH THE PATIENT HITTING THEMSELVES. THE ICD WAS PROGRAMMED TO THE PREVIOUS SETTINGS AND REMAINS IN USE.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT CONTINUES TO PRESENT AT THE HOSPITAL ON A REGULAR BASIS DUE TO AUDIBLE ALERTS. ADDITIONAL ELECTRICAL RESETS ARE SUBSEQUENTLY FOUND AND THE ICD IS PROGRAMMED BACK TO PREVIOUS SETTINGS. IT WAS DECIDED THAT THE PATIENT WILL BE MONITORED REMOTELY ON A DAILY BASIS AND WILL CHECK IN AT THE HOSPITAL ONCE PER WEEK. THE PATIENT IS ALSO BEING TREATED WITH MEDICATION IN AN ATTEMPT TO REDUCE THE SELF-INJURING BEHAVIOR AS IT IS STILL BELIEVED THAT THE ALERTS AND RESETS ARE COINCIDING WITH THE PATIENT HITTING THEMSELVES IN THE ICD POCKET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ELECTRICAL RESET HAD BEEN DISCOVERED DURING A ROUTINE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE CHECK. THE PATIENT MAY HAVE AUTISM AND IT WAS REVEALED THAT THE PATIENT SOMETIMES HITS THE ICD POCKET. THE ICD WAS REPROGRAMMED BACK TO ORIGINAL SETTINGS. THE PATIENT PRESENTED A FEW DAYS LATER DUE TO AN AUDIBLE ALERT. WIRELESS TELEMETRY COULD NOT BE ESTABLISHED WITH THE ICD. IT WAS DETERMINED THAT AN ELECTRICAL RESET HAD OCCURRED ON EACH OF THE THREE PREVIOUS DAYS. A HIGH NUMBER OF SHORT INTERVAL COUNTS (SIC) WERE ALSO OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. IT WAS DECIDED TO MONITOR THE PATIENT¿S CONDITION AND NO FURTHER INTERVENTION WAS DONE. THE ICD AND RV LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471566 SECURA DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC EUROPE SARL D234DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00025 YR Required Intervention