MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) GALLANT HF; NO MATCH

Model Number CDHFA500Q

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

Patient Problem Wound Dehiscence (1154)

Event Date 12/07/2023

Event Type  Injury  

Event Description

It was reported that the asymptomatic patient presented for a follow-up in clinic with wound dehiscence on the incision site.The physician explanted the implantable cardioverter defibrillator (icd) and the leads to resolve the issue.The patient was in stable condition throughout the procedure.

Manufacturer Narrative

The product was returned.Interrogation and visual inspection were normal.Analysis found that the device was received with battery voltage above elective replacement indicator (eri) level.

• Brand Name: GALLANT HF
• 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: 18396349
• MDR Text Key: 331357913
• Report Number: 2017865-2023-95608
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05415067032010
• UDI-Public: 05415067032010
• 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,Followup,Followup
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CDHFA500Q
• Device Lot Number: A000143086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2023
• 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: OPTISURE MRI LEAD; QUARTET LEADS; TENDRIL LEADS
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male