MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET LEAD SMALL-S, 86 CM; PERMANENT PACEMAKER ELECTRODE

Model Number 1456Q/86

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Vascular Dissection (3160); Pericardial Effusion (3271)

Event Date 12/05/2020

Event Type  Injury  

Manufacturer Narrative

This product is registered as a combination product.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer reference number: 2017865-2020-25197.It was reported that the patient presented for an upgrade to biventricular implantable cardioverter defibrillator.During the procedure, the left ventricle lead could not be implanted as the delivery of the lead to the target vessel was unsuccessful.The lead was removed and the venogram balloon was placed to redefine the target vessel.Upon injection of contrast it was noted that the coronary sinus was dissected and a small amount of contrast infiltrated the pericardium.The delivery system was removed and the lead was successfully replaced.A cardiac echocardiogram was done post procedure which demonstrated a very mild pericardial effusion.It was decided not to intervene on the effusion.Patient was stable.

Manufacturer Narrative

Correction:h6: investigation conclusion should have been 67 - no problem detected instead of 11 - conclusion not yet available.

Manufacturer Narrative

Analysis was normal.No anomalies were found.

• Brand Name: QUARTET LEAD SMALL-S, 86 CM
• 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: 11094485
• MDR Text Key: 224275290
• Report Number: 2017865-2020-25196
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734510158
• UDI-Public: 05414734510158
• Combination Product (y/n): N
• 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,Followup
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: 1456Q/86
• Device Catalogue Number: 1456Q/86
• Device Lot Number: A000102567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER; CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER
• Patient Outcome(s): Other
• Patient Age: 75 YR