BEUDAMED
    FDA Adverse Event Death Summary report: N

    ATTAIN OTW

    MDR report key: 1864366 · Received October 12, 2010

    Report

    Report Number
    2649622-2010-11881
    Event Type
    Death
    Date Received
    October 12, 2010
    Date of Event
    April 15, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P010015/S012
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) DEFIB CONDUCTOR DISTORTED, BLOOD IN/ON HELIX/LOBE MECHANISM. FULL LEAD WAS RETURNED AND ANALYZED. THE PATIENT WAS MADE "DO NOT RESUSCITATE (DNR)" AND VENTRICULAR TACHYCARDIA AND VENTRICULAR FIBRILLATION DETECTIONS WERE DISABLED. THE PHYSICIAN REPORTED CAUSE OF DEATH AS PULMONARY EMBOLISM. THERE WAS NO AUTOPSY PERFORMED AND NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE OR LEAD RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE MANUFACTURER'S CLINICAL SPECIALIST THAT DURING THE IMPLANT PROCEDURE, THE PHYSICIAN WAS "PUSHING AND PULLING TOO FAST" FROM THE SAFE SHEATH VALVE WHICH OCCURRED "OUTSIDE THE BODY." IT WAS FURTHER REPORTED THAT THE "PUSHING AND PULLING" STRETCHED THE COIL. AN IMPLANT ATTEMPT "TO THE LEVEL OF THE SUPERIOR VENA CAVA" WAS REPORTED, BUT THE LEAD WAS EXPLANTED AND REPLACED WITH ANOTHER 6947 LEAD. BASED ON FOLLOW-UP, IT WAS FURTHER REPORTED THE NEXT MORNING, THE PATIENT HAD A POST OPERATIVE CHEST X-RAY AND ALL LEAD POSITIONS WERE UNCHANGED. THE PATIENT WAS COMPLAINING OF SHORTNESS OF BREATH AND VENTRICULAR TACHYCARDIA EPISODES WERE OBSERVED ON THE MONITOR. THE PATIENT CODED AND THE ECHOCARDIOGRAM DONE DURING THE CODE SHOWED NO EVIDENCE OF CARDIAC TAMPONADE. THE NURSE WAS CALLED TO INTERROGATE THE DEVICE DURING THE CODE, BUT THE PHYSICIAN DECIDED NOT TO INTERROGATE AND CPR WAS CONTINUED FOR "AT LEAST 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN OTW IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4194 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death STYLET