MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) UNIFY QUADRA CRT-D, US MODEL, DF1COMP; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3249-40

Device Problems Failure to Convert Rhythm (1540); Inappropriate or Unexpected Reset (2959); Data Problem (3196)

Patient Problems Arrhythmia (1721); Discomfort (2330)

Event Date 02/06/2023

Event Type  Injury  

Event Description

It was reported that the patient presented to the emergency room with discomfort after repeated shocks from the implantable cardioverter defibrillator failed to resolve their arrythmia.External defibrillation had to be performed, which subsequently caused the device to go into back up mode.While in reset, defibrillation therapies were not available.The device was successfully reprogrammed.However, due to a data issue, previous device records were unable to be reviewed.The patient was stable following programming changes.

• Brand Name: UNIFY QUADRA CRT-D, US MODEL, DF1COMP
• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 16373015
• MDR Text Key: 309503141
• Report Number: 2017865-2023-08889
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734504539
• UDI-Public: 05414734504539
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: CD3249-40
• Device Catalogue Number: CD3249-40
• Device Lot Number: S000037189
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/06/2023
• Initial Date FDA Received: 02/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2017
• 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): Other