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

Model Number 1458QL/86

Device Problem Difficult to Insert (1316)

Patient Problems Cardiac Tamponade (2226); Cardiac Perforation (2513); Vascular Dissection (3160)

Event Date 05/20/2019

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: 2938836-2019-04386, related manufacturer reference number: 2938836-2019-04387.It was reported that during an initial implant procedure, after implantation of a right ventricular pacing lead, the physician attempted to implant a quadripolar passive lead in the left ventricle.Physician complained of tightness of sub-selector around the lv lead.The lead couldn¿t be advanced all the way through the sub selector of both the inner and outer catheters.Another inner catheter was used to complete the procedure.However, the distal coronary sinus (cs) was perforated/ dissected while using the cps universal delivery system outer and inner catheters.The perforation resulted in significantly lowered blood pressure, cardiac tamponade, and loss of pulse readings.The patient lost a significant amount of blood.The patient was administered chest compressions, received multiple external defibrillator shocks for spontaneous vf, and was administered an intrathoracic needle and chest tube to evacuate blood from the pericardium.The implant of the left ventricular lead was discontinued after the tamponade occurred.Upon hemodynamic normalization of the patient, a right atrial lead and a dual chamber pacemaker were implanted to complete the implant procedure.At the end of the procedure, the patient was minimally responsive, and the decision was made to attempt targeted body temperature management for more than 24 hours.The patient¿s current condition is stable.

• Brand Name: QUARTET
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 8667859
• MDR Text Key: 146962671
• Report Number: 2938836-2019-04385
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734510219
• UDI-Public: 05414734510219
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: 1458QL/86
• Device Catalogue Number: 1458QL/86
• Device Lot Number: A000065557
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2018
• 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: CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER; CPS QUARTET INNER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 88 YR