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 Therapy Delivered to Incorrect Body Area (1508)

Patient Problems Discomfort (2330); Heart Failure/Congestive Heart Failure (4446)

Event Date 08/03/2022

Event Type  Injury  

Event Description

It was reported that the patient presented for a follow-up in clinic for a generator exchange procedure.It was noted that the left ventricular (lv) lead was deactivated in (b)(6) of 2021 due to diaphragmatic stimulation which caused the patient to experience discomfort.Due to the lack of pacing in the lv chamber, the patient experienced worsening heart failure symptoms.The lv lead was capped and new lv lead was successfully implanted on (b)(6) 2022.The patient was stable throughout the procedure.

• 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 15192673
• MDR Text Key: 297529925
• Report Number: 2017865-2022-17149
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 05414734510189
• UDI-Public: 05414734510189
• Combination Product (y/n): Y
• 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 Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: 1457Q/86
• Device Catalogue Number: 1457Q/86
• Device Lot Number: A000046061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/03/2022
• Initial Date FDA Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2017
• 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: DURATATACHY MRI LEADS; QUADRAASSURA MP; TENDRILLEADS
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female