BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROTECTA DR

    MDR report key: 2103173 · Received May 25, 2011

    Report

    Report Number
    2647346-2011-00731
    Event Type
    Death
    Date Received
    May 25, 2011
    Date of Event
    May 17, 2011
    Report Date
    July 26, 2016
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO, MED REL
    Product Code
    LWS
    PMA / PMN Number
    P980016/S211
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. FURTHER DETAILS AND CAUSE OF DEATH HAVE BEEN REQUESTED, BUT NOT YET RECEIVED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. 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

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. FURTHER DETAILS AND CAUSE OF DEATH HAVE BEEN REQUESTED BUT NOT YET RECEIVED. (B)(4). 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.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE CORONERS OFFICE AND REPORTED THE CAUSE OF DEATH AS ARTERIOSCLEROTIC CARDIOVASCULAR DISEASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A DEVICE CHANGE OUT AND WITHIN HOURS OF THE NEWLY IMPLANTED DEVICE HAD MANY FREQUENT VENTRICULAR TACHYCARDIA EPISODES. THE PATIENT RECEIVED OVER 25 APPROPRIATE AND SUCCESSFUL SHOCKS. THE UNDERLYING RHYTHM WAS NOTED TO BE JUNCTIONAL. THE PATIENT WAS TAKEN BACK INTO THE OPERATING ROOM AS VENTRICULAR TACHYCARDIA EPISODES AND SUCCESSFUL THERAPY CONTINUED. THE PATIENT WENT INTO PULSELESS ELECTRICAL ACTIVITY AFTER A REVISION AND CARDIOPULMONARY RESUSCITATION WAS UNSUCCESSFUL. PREVIOUS TO THIS CHANGE-OUT THE PATIENT WAS EXTREMELY SICK WITH END-STAGE KIDNEY FAILURE, MULTIPLE INFECTIONS IN LEG AND PERITONITIS, AND MULTIPLE VENTRICULAR TACHYCARDIA EPISODES THAT HAD BEEN TREATED EXTERNALLY. NO COMPLAINTS OR ALLEGATIONS THAT THE DEVICE MALFUNCTIONED HAVE BEEN MADE. THE OFFICIAL CAUSE OF DEATH HAS BEEN REQUESTED AND NOT YET RECEIVED. THE LEAD WAS ATTEMPTED DURING THE PROCEDURE BUT THE IMPLANTER HAD DIFFICULTY POSITIONING IT. A NEW LEAD WAS USED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A DEVICE CHANGE OUT AND WITHIN HOURS OF THE NEWLY IMPLANTED DEVICE HAD MANY FREQUENT VENTRICULAR TACHYCARDIA EPISODES. THE PATIENT RECEIVED OVER 25 APPROPRIATE AND SUCCESSFUL SHOCKS. THE UNDERLYING RHYTHM WAS NOTED TO BE JUNCTIONAL. THE PATIENT WAS TAKEN BACK INTO THE OPERATING ROOM AS VENTRICULAR TACHYCARDIA EPISODES AND SUCCESSFUL THERAPY CONTINUED. THE PATIENT WENT INTO PULSELESS ELECTRICAL ACTIVITY AFTER A REVISION AND CARDIOPULMONARY RESUSCITATION WAS UNSUCCESSFUL. PREVIOUS TO THIS CHANGEOUT THE PATIENT WAS EXTREMELY SICK WITH END-STAGE KIDNEY FAILURE, MULTIPLE INFECTIONS IN LEG AND PERITONITIS, AND MULTIPLE VENTRICULAR TACHYCARDIA EPISODES THAT HAD BEEN TREATED EXTERNALLY. NO COMPLAINTS OR ALLEGATIONS THAT THE DEVICE MALFUNCTIONED HAVE BEEN MADE. THE OFFICIAL CAUSE OF DEATH HAS BEEN REQUESTED AND NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTECTA DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MDT PUERTO RICO OPERATIONS CO, MED REL D334DRG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death| H| L| R 7122 COMPETITOR IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD