MAUDE Adverse Event Report: ST. JUDE ST. JUDE'S/ QUADRA; QUADRA ASSURA BIV DEFIBRILLATOR

Model Number CD3369-40Q

Device Problem Vibration (1674)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/04/2017

Event Type  Injury  

Event Description

This st.Jude biventricular icd, implanted on (b)(6) 2016 model cd 3369-40q, started vibrating repeatedly every approximately every 10 hours.There is currently no advice on this line of devices.

• Brand Name: ST. JUDE'S/ QUADRA
• Type of Device: QUADRA ASSURA BIV DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE; st. paul MN 55117
• MDR Report Key: 6278968
• MDR Text Key: 65941064
• Report Number: MW5067454
• Device Sequence Number: 1
• Product Code: NIK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CD3369-40Q
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 85