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

Model Number CDDRA500Q

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 09/28/2023

Event Type  malfunction  

Event Description

Related manufacture reference number: (b)(4).It was reported that the patient was symptomatic of perforation caused by the right ventricular lead.During reposition, it was noted that the helix of the right ventricular lead failed to extend.The reported lead was explanted and a new lead was used.During implant of the new right ventricular lead, it was noted that the set screw of the implantable cardioverter defibrillator header was stripped and the new lead could not be screwed in.The implantable cardioverter defibrillator was explanted and a the procedure was completed with a new implantable cardioverter defibrillator on (b)(6)2023.The patient was in stable condition.

Manufacturer Narrative

The reported event of a set screw anomaly was confirmed.As received, a device was returned for analysis.A device history record (dhr) review was performed and all required manufacturing processes and inspection steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.The ventricular set screw hex cavity was found to be stripped.The cause of the stripped set screw hex cavity was procedure related.

• Brand Name: GALLANT DR
• 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: 17962302
• MDR Text Key: 326033594
• Report Number: 2017865-2023-50139
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05415067032003
• UDI-Public: 05415067032003
• 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
• Report Date: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CDDRA500Q
• Device Lot Number: A000145223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2023
• 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: TENDRIL LEAD
• Patient Age: 76 YR
• Patient Sex: Female