BEUDAMED
    FDA Adverse Event Death Summary report: N

    CRYSTALLINE

    MDR report key: 1813553 · Received August 25, 2010

    Report

    Report Number
    2649622-2010-08909
    Event Type
    Death
    Date Received
    August 25, 2010
    Date of Event
    August 16, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. EVALUATION SUMMARY: (B)(4) NO ANOMALIES FOUND, BOOD IN/ON HELIX/LOBE MECHANISM. FULL LEAD RETURNED AND ANALYZED.

    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.

    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. EVALUATION SUMMARY (B)(4) NO ANOMALIES FOUND, BOOD IN/ON HELIX/LOBE MECHANISM. FULL LEAD RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT OF THE LEAD, THE PATIENT DEVELOPED A CARDIAC TAMPONADE WITH HYPOTENSION AND DIED. THE PHYSICIAN SUSPECTS LEAD PERFORATION INTO THE MYOCADIUM. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT OF THE LEAD, THE PATIENT DEVELOPED A CARDIAC TAMPONADE WITH HYPOTENSION AND DIED. THE PHYSICIAN SUSPECTS LEAD PERFORATION INTO THE MYOCADIUM. FOLLOW UP WITH THE PHYSICIAN CONFIRMED THE CAUSE OF DEATH TO BE MYOCARDIAL PERFORATION "BECAUSE OF THE SCREWING LEAD." WAS CONFIRMED BY ECHOCARDIOGRAM. AUTOPSY WAS NOT DONE PER THE FAMILY. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT OF THE LEAD, THE PATIENT DEVELOPED A CARDIAC TAMPONADE WITH HYPOTENSION AND DIED. THE PHYSICIAN SUSPECTS LEAD PERFORATION INTO THE MYOCARDIUM. FOLLOW UP WITH THE PHYSICIAN CONFIRMED THE CAUSE OF DEATH TO BE MYOCARDIAL PERFORATION AS CONFIRMED BY ECHOCARDIOGRAM. AUTOPSY WAS NOT DONE PER THE FAMILY. IT WAS LATER REPORTED THE PHYSICIAN "DOES NOT FEEL THAT THE DEATH OF THE PATIENT COULD BE BECAUSE OF THE PRODUCT." AFTER DOING AN ECHOCARDIOGRAM, HE CONFIRMED THE PERFORATION "BECAUSE OF THE SCREWING LEAD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALLINE ASKU DTB MEDTRONIC PUERTO RICO, INC. ICQ09B ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Death