MAUDE Adverse Event Report: ST. JUDE MEDICAL IMPLANTABLE DEFIBRILLATOR; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER WITH CARDIAC RESYNC

Model Number CD3365-40Q

Device Problem Device Alarm System (1012)

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

Event Date 04/08/2018

Event Type  Injury  

Event Description

Received battery depletion vibration alarm three times.Have implanted st jude defibrillator, model #cd3365-40q, serial # (b)(4).Still implanted.

• Brand Name: IMPLANTABLE DEFIBRILLATOR
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER WITH CARDIAC RESYNC
• Manufacturer (Section D): ST. JUDE MEDICAL ; 5050 nathan lane north ; plymouth MN 55442
• MDR Report Key: 8138574
• MDR Text Key: 129742262
• Report Number: MW5081873
• 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: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CD3365-40Q
• Device Catalogue Number: CD3365-40Q
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/05/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 78