MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) QUADRA ASSURA MP ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3369-40Q

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Pulmonary Edema (2020); Respiratory Distress (2045); Heart Failure (2206); Loss Of Pulse (2562)

Event Date 01/27/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during the implant procedure, the patient had two brief episodes of asystole and pulseless electrical activity (pea), which required 2 minutes of cpr and administration of epinephrine and atropine.The patient's condition stabilized and the implant procedure was completed without further issues.Pre-discharge, patient became severely agitated, began kicking, hitting, removing his o2 & attempting to get out of bed.Placed in restraints, sedated, continues drowsy and intermittently agitated.Two days post-implant, while still in the hospital, the patient exhibited symptoms of acute decompensated heart failure, including respiratory distress and pulmonary edema, treated with oxygen, bipap and iv diuretics.No further information is available.

Event Description

New information received notes that adverse event was related to implant procedure and the event was resolved without sequelae.Attempts have been made to obtain how the issue was resolved; however, no response has been received.

• Brand Name: QUADRA ASSURA MP ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6349126
• MDR Text Key: 67959352
• Report Number: 2938836-2017-15773
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: CD3369-40Q
• Device Lot Number: A000030633
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: (B)(4); (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR