MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) GALLANT DR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CDDRA500Q

Device Problems Loose or Intermittent Connection (1371); Connection Problem (2900)

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

Event Date 01/30/2023

Event Type  malfunction  

Event Description

It was reported that during an implant procedure, the implantable cardioverter defibrillator being used exhibited loose connection on the device header, resulting in inadequate lead insertion alleged on the device.The device was not used and another device was used to successfully complete the procedure.The patient was discharged with no additional adverse consequences reported.

Manufacturer Narrative

The reported event of set screw anomaly was confirmed.The device was above elective replacement indicator (eri) upon receipt.Analysis revealed the ventricular set screw was stripped and contained septum material inside the hex cavity.This material in the hex cavity prevented full insertion of the torque driver and was the cause of the reported event.The set screw anomaly was consistent with having occurred during the procedure.

• Brand Name: GALLANT DR
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• 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: 16399001
• MDR Text Key: 309792521
• Report Number: 2017865-2023-10252
• 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: 05/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CDDRA500Q
• Device Catalogue Number: CDDRA500Q
• Device Lot Number: P000153883
• 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: 04/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2022
• 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
• Treatment: DURATA TACHY MRI; TENDRIL SDX; TENDRIL SDX
• Patient Age: 88 YR
• Patient Sex: Male
• Patient Weight: 83 KG