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); Contamination of Device Ingredient or Reagent (2901)

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

Event Date 03/18/2023

Event Type  malfunction  

Event Description

Related manufacturer reference number: 2017865-2023-16924.It was reported the patient presented to the hospital decompensating.Upon interrogation, it was noted the right ventricular lead exhibited a drop in pacing impedance.An echocardiogram showed the right ventricular lead had perforated and a pericardial effusion which required pericardiocentesis.While explanting the right ventricular lead, the helix appeared to be bent.The right ventricular lead was explanted and replaced.When connecting the right ventricular lead to the chronic implantable cardioverter defibrillator (icd), something was blocking the wrench from engaging with the set screw to tighten down the lead.The icd was explanted and replaced.The patient was in stable condition after the procedure.

Manufacturer Narrative

The reported event of set screw anomaly was confirmed.The implantable cardioverter defibrillator (icd) was returned for analysis.Analysis revealed the right ventricular set screw was stripped, preventing full insertion and engagement 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: 16696657
• MDR Text Key: 312939565
• Report Number: 2017865-2023-16923
• 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: 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2023
• 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: P000153247
• 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: 04/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2022
• 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: TENDRIL STS
• Patient Age: 57 YR
• Patient Sex: Male