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

Model Number 1457Q/86

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/04/2019

Event Type  Injury  

Manufacturer Narrative

Further information was requested but not received.The results /method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Manufacturer report number: 2017865-2019-18689.It was reported that the both left ventricular leads were implanted and explanted on (b)(6) 2019 due to unknown malfunction.No patient consequences were reported.

Manufacturer Narrative

Analysis was normal.No anomalies were found.

• Brand Name: QUARTET LEAD DOUBLE BEND, 86 CM
• 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: 9533663
• MDR Text Key: 173252727
• Report Number: 2017865-2019-18690
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 05414734510189
• UDI-Public: 05414734510189
• 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: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 1457Q/86
• Device Catalogue Number: 1457Q/86
• Device Lot Number: A000085116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2019
• 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: 69 YR