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

Model Number 1458Q/86

Device Problems Failure to Capture (1081); Device Dislodged or Dislocated (2923)

Patient Problems Dyspnea (1816); Fatigue (1849); Twiddlers Syndrome (2114)

Event Date 07/16/2020

Event Type  Injury  

Manufacturer Narrative

This product is registered as a combination product.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

Manufacturer report number: 2017865-2020-10537.Manufacturer report number: 2017865-2020-10538.Manufacturer report number: 2017865-2020-10539.It was reported that the patient presented in clinic after feeling fatigued and experiencing dyspnea.Upon interrogation, it was revealed that the right atrial lead, right ventricular lead, and left ventricular lead exhibited loss of capture.X-ray noted that the patient had twiddled his implantable cardioverter defibrillator and pulled the right atrial lead, right ventricular lead, and left ventricular lead out of place.The patient presented to revision procedure on (b)(6) 2020.During procedure, it was noted that the left ventricular lead had many blood clots in it.Therefore, the left ventricular lead was explanted and replaced.The right atrial lead and right ventricular lead were both re-positioned.Lastly, the implantable cardioverter defibrillator was re-positioned back in the same spot under the skin.The device and lead measurements all functioned appropriately after repositioning.The patient was stable post procedure.

• 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 10365957
• MDR Text Key: 201664957
• Report Number: 2017865-2020-10536
• 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
• Report Date: 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 1458Q/86
• Device Catalogue Number: 1458Q-86
• Device Lot Number: A000095361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2020
• 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: DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR; QUADRA ASSURA MP ICD; TENDRIL STS
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 95