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

Model Number 1458Q/86

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Cardiac Tamponade (2226)

Event Date 12/04/2019

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer reference number: 2017865-2019-17983, 2017865-2019-17985.It was reported that the patient presented for initial implant.The right ventricular lead (rv), right atrial (ra) lead, and left ventricular (lv) lead were placed and rested appropriately.During procedure, fluoroscopy testing to check final lead placement noted the rv lead was no longer in its original position.Right ventricular perforation was noted.The patient subsequently developed tachycardia and hypotension.The physician suspected tamponade, and tamponade was confirmed with intraoperative echocardiogram.Furthermore, no pulse was detected and acls protocol was imitated.Pericardiocentesis was performed and tamponade was relieved.The patient¿s vital signs were stabilized.The origin of the tamponade was not entirely known.The physician felt the rv lead perforated the right ventricle but did not felt it was a result of the lead itself but possibly that the rv lead could have been advanced during placement of the lv lead.All the leads were removed.The patient was stable.

Manufacturer Narrative

As received, a complete lead was returned in one piece.Electrical testing did not find any indication of conductor fractures or internal shorts.Visual inspection and x-ray examination of the lead did not find any anomalies.The s-curve hump height was measured to be within product 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: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 9471083
• MDR Text Key: 170949421
• Report Number: 2017865-2019-17984
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734503198
• UDI-Public: 05414734503198
• 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,Followup
• Report Date: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: 1458Q/86
• Device Lot Number: A000086292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2019
• 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 Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 73