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

Model Number 1458Q/86

Device Problems Positioning Failure (1158); Pacing Inadequately (1442)

Patient Problems Dyspnea (1816); Heart Failure (2206); No Known Impact Or Consequence To Patient (2692)

Event Date 01/25/2019

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

It was reported that an x-ray was performed on (b)(6) 2019 and it was observed that the right ventricular and the left ventricular lead did not have optimal separation, leading to suboptimal cardiac resynchronization therapy (crt).The left ventricular lead was capped and replaced on (b)(6) 2019.The patient was stable throughout.

Event Description

New information received states that the patient presented in clinic with acute shortness of breath and it was confirmed that his symptoms were caused by heart failure after heart catheterization.An electrophysiologist performed a x-ray and it was observed that the left ventricular lead was located in a posterior branch, therefore, there was not enough separation from rv lead pacing at the apex of the heart, hence there was no ideal rv-lv separation and the physician suspected that the patient was receiving suboptimal cardiac resynchronization therapy.It was believed that patient would respond better if the rv ¿ lv separation was increased by altering the lead location.Hence, a new lead was implanted in a posterior lateral branch.The patient was stable post procedure.

• 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: 8328732
• MDR Text Key: 135846424
• Report Number: 2938836-2019-01018
• Device Sequence Number: 1
• Product Code: OJX
• 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: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: 1458Q/86
• Device Lot Number: A000006681
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2015
• 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: 74 YR