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

Model Number CD3357-40C

Device Problem Migration (4003)

Patient Problem Twiddlers Syndrome (4563)

Event Date 08/29/2022

Event Type  Injury  

Event Description

Related manufacturer reference number:2017865-2022-38498, related manufacturer reference number:2017865-2022-38500.It was reported that the patient manually rotated the generator.The implantable cardioverter defibrillator exhibited migration due to twiddler's syndrome.The atrial lead exhibited failure to capture, high pacing impedance, p wave amplitude variation, migration due to twiddler's syndrome and lead slack issue.The left ventricle lead exhibited migration due to twiddler's syndrome and lead slack issue.The implantable cardioverter defibrillator was explanted and replaced.The atrial lead was capped and replaced during the same procedure on (b)(6) 2022.The left ventricle lead was explanted.Patient was stable.

• 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 15443501
• MDR Text Key: 300118003
• Report Number: 2017865-2022-38499
• 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: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: CD3357-40C
• Device Catalogue Number: CD3357-40C
• Device Lot Number: A000001489
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2015
• 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: RIGHT VENTRICLE LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female