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

Model Number CDDRA500Q

Device Problems Loose or Intermittent Connection (1371); Failure to Disconnect (2541)

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

Event Date 08/23/2023

Event Type  malfunction  

Event Description

Related manufacturer reference numbers: 2017865-2023-42800.It was reported that the patient presented in clinic for initial implant procedure.During procedure, it was found that the implantable cardioverter defibrillator (icd) atrial port set screw was stripped and the right ventricular (rv) was not able to be disconnected from the icd header after initial connection.Both the icd and the rv lead were not implanted and replaced by an alternate near at hand on (b)(6) 2023.Patient condition was recovering.

Manufacturer Narrative

The reported event of setscrew anomaly was confirmed.Final analysis revealed the atrial setscrew was backed out of its connector block as a result of unscrewing the setscrew too far.Both atrial and right ventricular setscrews were stripped and contained septum material inside their hex cavities.The backed-out atrial setscrew prevented full insertion of the torque driver and stripped right ventricular setscrew resulting in torque driver not being able to engage was the cause of the reported event.The setscrew anomaly was consistent with having occurred during the procedure.

• 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: 17727101
• MDR Text Key: 323159733
• Report Number: 2017865-2023-42799
• 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: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: P000166603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/23/2023
• Initial Date FDA Received: 09/12/2023
• Supplement Dates Manufacturer Received: 09/29/2023
• Supplement Dates FDA Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2023
• 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
• Patient Age: 72 YR
• Patient Sex: Male