MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET; PERMANENT PACEMAKER ELECTRODE

Model Number 1458QL/86

Device Problems Failure to Sense (1559); Device Dislodged or Dislocated (2923)

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

Event Date 02/06/2023

Event Type  Injury  

Event Description

Related manufacturer reference number: 2017865-2023-10834, related manufacturer reference number: 2017865-2023-10835.It was reported there was no sensing on the right atrial (ra) lead, right ventricular (rv) lead, and left ventricular (lv) lead.Chest x-ray revealed all three leads had dislodged due to twiddler¿s syndrome.The leads were explanted.The patient had no adverse outcome, and new leads were placed on the right side.

Event Description

Related manufacturer reference number: 2017865-2023-10834.Related manufacturer reference number: 2017865-2023-10838.It was reported there was no sensing on the right atrial (ra) lead, right ventricular (rv) lead, and left ventricular (lv) lead.Chest x-ray revealed all three leads had dislodged due to twiddler¿s syndrome.The leads were explanted.The patient had no adverse outcome, and new leads were placed on the right side.

Manufacturer Narrative

The reported events were lead dislodgement due to twiddler¿s syndrome and failure to sense was not confirmed.As received, a complete lead was returned in one piece.Visual examination of the lead did not find any anomalies.Electrical testing did not find any indication of conductor fractures or internal shorts.S-curve was measured to be within specification.

• Brand Name: QUARTET
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• 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: 16440359
• MDR Text Key: 310221948
• Report Number: 2017865-2023-10836
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734510219
• UDI-Public: 05414734510219
• Combination Product (y/n): Y
• 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: 05/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1458QL/86
• Device Catalogue Number: 1458QL/86
• Device Lot Number: A000124256
• 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: 05/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2022
• 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: GALLANT ICD
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female