MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) UNIFY QUADRA CRT-D, US MODEL, DF1COMP; NO MATCH

Model Number CD3249-40

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pocket Erosion (2013); Discomfort (2330)

Event Date 03/07/2024

Event Type  Injury  

Event Description

It was reported that a patient presented with pain at incision site.It was found that the implantable cardioverter defibrillator (icd) bag was ruptured and exuded a small amount of yellow pus.The icd was eroded out of the pocket.Culture was performed and the results were negative.The physician elected to explant the entire system.The patient condition was stable.

Manufacturer Narrative

Interrogation of the device revealed it was above elective replacement indicator (eri) when received. based on this information, the device was found to communicate appropriately with a merlin programmer and has not reached the elective replacement indicator (eri).

• Brand Name: UNIFY QUADRA CRT-D, US MODEL, DF1COMP
• 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: 19072224
• MDR Text Key: 339727499
• Report Number: 2017865-2024-38036
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734504539
• UDI-Public: (01)05414734504539(10)A000127133(17)231231
• 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
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: CD3249-40
• Device Lot Number: A000127133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2022
• 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; Life Threatening