MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) UNIFY CRT-D; NO MATCH

Model Number CD3231-40

Device Problems Break (1069); Inappropriate or Unexpected Reset (2959)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/15/2023

Event Type  Injury  

Event Description

It was reported, a patient's implantable cardioverter defibrillator (icd) presented in backup vvi mode.For an unknown reason.The internal components were also found damaged.And a reset could not be performed.The device was explanted in a procedure on (b)(6) 2023.The patient was stable.

Manufacturer Narrative

The reported event of backup operation was confirmed.Analysis of device image found the device went into backup operation due to a power-on-reset (por).After the device was restored from backup mode, functional testing was performed.Telemetry, impedance, sensing, pacing and high voltage (hv) output functions of the device were tested and found to be normal.The backup operation could not be reproduced.The cause of the reported event could not be determined.

Manufacturer Narrative

Correction: h6.

Manufacturer Narrative

Correction: h6.

• Brand Name: UNIFY CRT-D
• Type of Device: NO MATCH
• 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: 17627668
• MDR Text Key: 322018766
• Report Number: 2017865-2023-39329
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734504362
• UDI-Public: 05414734504362
• 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,Followup,Followup,Followup
• Report Date: 10/20/2023

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: 09/30/2022
• Device Model Number: CD3231-40
• Device Lot Number: A000107199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/15/2023
• Initial Date FDA Received: 08/25/2023
• Supplement Dates Manufacturer Received: 10/05/2023; 10/20/2023; 10/20/2023
• Supplement Dates FDA Received: 10/17/2023; 10/20/2023; 10/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2021
• 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