MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) UNIFY ASSURA CRT-D RF HV; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3357-40C

Device Problems Premature Discharge of Battery (1057); Failure to Interrogate (1332)

Patient Problems Bradycardia (1751); Complete Heart Block (2627)

Event Date 11/13/2019

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported that the patient presented to the emergency room in complete heart block.The implantable cardioverter defibrillator was not able to be interrogated.At in clinic check two months ago, the battery longevity was 1 to 2 years.The device was explanted and replaced.The patient was stable before, during and after the procedure.

Manufacturer Narrative

Statement should include information regarding the patient's heart rate of 35 bpm when presented in the emergency room.(b)(4).

Event Description

It was reported that the patient presented to the emergency room in complete heart block with a heart rate of 35 bpm.

• Brand Name: UNIFY ASSURA CRT-D RF HV
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 9324190
• MDR Text Key: 166519991
• Report Number: 2017865-2019-16463
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734508186
• UDI-Public: 05414734508186
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970013
• 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: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Model Number: CD3357-40C
• Device Catalogue Number: CD3357-40C
• Device Lot Number: 4373044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2013
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR