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

Model Number 1458Q/86

Device Problems Therapy Delivered to Incorrect Body Area (1508); Failure to Disconnect (2541); Capturing Problem (2891); Device Dislodged or Dislocated (2923)

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

Event Date 08/19/2021

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Related manufacturer reference number: 2017865-2021-29674.It was reported a patient's atrial lead presented with noise and low pacing impedance.The left ventricular lead presented with a high capture threshold.The atrial lead was explanted and replaced in a procedure on (b)(6) 2021, while the left ventricular lead was capped and replaced in the same operation.Post procedure the patient was recovering.

Event Description

Related manufacturer reference number: 2017865-2021-29674.Related manufacturer reference number: 2017865-2021-31968.It was reported a patient's atrial lead presented with noise and low pacing impedance.The left ventricular lead (lv) presented with a high capture threshold.The atrial lead was explanted and replaced in a procedure on (b)(6) 2021, the lv lead was attempted to be explanted but was unsuccessful.Post procedure the patient was recovering.New information received notes the left ventricular (lv) lead presented with dislodgement.There was also diaphragmatic pacing noted.This was addressed in a separate procedure on (b)(6) 2021 in which there was difficulty separating the lv lead from the right ventricular lead due to partial adherence.Once a laser was applied, the lv lead was explanted and replaced.Post-procedure the patient status was unknown.

• 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
• MDR Report Key: 12416053
• MDR Text Key: 269604491
• Report Number: 2017865-2021-29675
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734503198
• UDI-Public: 05414734503198
• Combination Product (y/n): Y
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: 1458Q/86
• Device Catalogue Number: 1458Q-86
• Device Lot Number: A000078063
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2088TC/52 TENDRILLEAD; 7120Q/58 DURATATACHY LEADS UMRI PR; 2088TC/52 TENDRILLEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR