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 Unspecified Infection (1930); Pocket Erosion (2013)

Event Date 09/21/2023

Event Type  Injury  

Manufacturer Narrative

A device history record (dhr) review was performed.And all required manufacturing processes and inspections steps were confirmed, to be completed per the requirements.The device met specifications, prior to leaving abbott manufacturing facilities.Review of the sterilization records confirmed, normal sterilization cycles for the products.The cause of infection could not be determined.

Event Description

It was reported, that the patient presented to the hospital with infection and skin erosion at device pocket site.The device pocket was noted, to swelling, ulceration and discharge.The patient was treated with antibiotics and pocket debridement.The implantable cardioverter defibrillator (icd), right atrial (ra) lead, right ventricular lead (rv) and left ventricular (lv) lead were explanted.Information received notes, the icd was re-implanted again on (b)(6) 2023.After supposed appropriate sterilization.The ra, rv and lv leads were replaced.The patient was in stable condition throughout the procedure.

• 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: 18098353
• MDR Text Key: 327697776
• Report Number: 2017865-2023-51884
• 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: 11/09/2023

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: CD3249-40
• Device Lot Number: A000132533
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/20/2023
• Initial Date FDA Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention