MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ASSURA MP ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3369-40Q

Device Problem No Pacing (3268)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/15/2022

Event Type  Injury  

Event Description

Related manufacturer report number: 2017865-2022-40621; related manufacturer report number: 2017865-2022-40622.It was reported that the patient presented for routine implant of a bi-ventricular implantable cardioverter defibrillator (icd).After the pocket was closed and the patient was sent to recovery where it was noted that there was loss of left ventricular (lv) capture.The patient was sent back to surgery where the physician intended to reposition the lv lead.The lead was tested on the pacing system analyzer (psa) and was able to induce lv capture.However, once the lead was reconnected to the icd, no capture was observed.The device was explanted and replaced, and the lead was connected to the new device, still the issue persisted.The physician then decided to explant and replace the lv lead.The replacement lead was test via psa and capture was induced and parameters were normal.The replacement lead was then connected to the replacement icd but failed to capture.The procedure was completed without the placement of a lv lead.The were no patient consequences.

Manufacturer Narrative

The reported event of no pacing output was not confirmed by analysis.Pacing signals from all leads were measured and found to be normal.Telemetry, impedance, sensing, pacing, and high voltage (hv) output functions of the device were tested and found to be normal.

• Brand Name: QUADRA ASSURA MP ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• 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: 15546555
• MDR Text Key: 301234850
• Report Number: 2017865-2022-40620
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734508377
• UDI-Public: 05414734508377
• 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 Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/19/2022

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: 01/31/2024
• Device Model Number: CD3369-40Q
• Device Catalogue Number: CD3369-40Q
• Device Lot Number: A000120079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/15/2022
• Initial Date FDA Received: 10/05/2022
• Supplement Dates Manufacturer Received: 10/07/2022
• Supplement Dates FDA Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2022
• 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 TACHY MRI; TENDIL
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male