BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURA DR

    MDR report key: 2202143 · Received August 11, 2011

    Report

    Report Number
    6000094-2011-01348
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    March 31, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. 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. EVALUATION SUMMARY FOR (B)(4): THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. OVERSENSING, TWO SHORT V-V SENSED EVENTS OF LESS THAN 220 MS ARE OBSERVED IN THE RECORD, ONE ON THE (B)(6) 2010 AND ONE ON (B)(6) 2010 (2 EPISODES VENTRICULAR FIBRILLATION).

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. 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. EVALUATION SUMMARY FOR (B)(4): THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. OVERSENSING, TWO SHORT V-V SENSED EVENTS OF LESS THAN 220 MS ARE OBSERVED IN THE RECORD, ONE ON THE (B)(6) 2010 AND ONE ON (B)(6) 2010 (2 EPISODES VENTRICULAR FIBRILLATION).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, WHEN THE PATIENT WAS IMPLANTED WITH A PULSE ASSIST SYSTEM APPROXIMATELY SEVEN WEEKS AGO, THEY BEGAN FEELING AN INTENSE INTERMITTENT SHOCK-LIKE PAIN BELOW THE LEFT BREAST WHICH PERSISTS FOR A LONG TIME. THE PAIN COULD BE REPRODUCED IN THE CLINIC WHILE PACING THE VENTRICLE WITH CAPTURE. THE DEVICE WAS REPROGRAMMED AND CAPTURE MANAGEMENT WAS TURNED OFF. THE DEVICE IS STILL IN USE. IT WAS FURTHER REPORTED THAT THE PATIENT STILL SLIGHTLY FEELS THE VENTRICULAR STIMULATION. THE DEVICE WAS REPROGRAMMED AND IS STILL IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, WHEN THE PATIENT WAS IMPLANTED WITH A PULSE ASSIST SYSTEM APPROXIMATELY (B)(6) AGO, THEY BEGAN FEELING AN INTENSE INTERMITTENT SHOCK-LIKE PAIN BELOW THE LEFT BREAST WHICH PERSISTS FOR A LONG TIME. THE PAIN COULD BE REPRODUCED IN THE CLINIC WHILE PACING THE VENTRICLE WITH CAPTURE. THE DEVICE WAS REPROGRAMMED AND CAPTURE MANAGEMENT WAS TURNED OFF. THE DEVICE IS STILL IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECURA DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC S.A. D234DRG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention 4076 IMPLANTABLE PACING LEAD| C PULSE HEART ASSIST SYSTEM - COMPETITOR| 6947 IMPLANTABLE TACHY LEAD| 6947 IMPLANTABLE TACHY LEAD| 4076 IMPLANTABLE PACING LEAD| C PULSE HEART ASSIST SYSTEM - COMPETITOR