MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ASSURA MP ICD; NO MATCH

Model Number CD3369-40Q

Device Problem Incorrect Measurement (1383)

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

Event Date 07/13/2023

Event Type  Injury  

Manufacturer Narrative

Further information was requested but not received.

Event Description

Related manufacturer report number: 2017865-2023-37486.It was reported that the patient presented for in-clinic follow-up.A surface electrocardiogram (ekg) was placed, and it was noted no capture was exhibited by the left ventricular (lv) lead.A capture test was performed by the implantable cardioverter defibrillator, and the device appeared to capture the lv.However, the surface ekg morphology was unchanged.It was believed that a diagnostic anomaly had occurred.No intervention was reported.Further information was requested but not received.

Manufacturer Narrative

Additional information: b1, b2, b5, d6b, h1 and h6.

Event Description

New information received notes that the left ventricular lead lost capture due to the patient's anatomy, and there was no alleged lead malfunction.The lead was capped and replaced with an epicardial lead on (b)(6) 2023.The implantable cardioverter defibrillator was also replaced during the procedure.The patient was stable.

Manufacturer Narrative

The reported event of measurement issue was not confirmed in lab.Visual inspection of the septum and setscrew did not reveal any anomaly that could contribute to the reported event.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: NO MATCH
• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 17452419
• MDR Text Key: 320335633
• Report Number: 2017865-2023-37490
• 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,Followup
• Report Date: 10/18/2023

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: 08/31/2023
• Device Model Number: CD3369-40Q
• Device Lot Number: A000113489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/13/2023
• Initial Date FDA Received: 08/03/2023
• Supplement Dates Manufacturer Received: 08/04/2023; 10/03/2023
• Supplement Dates FDA Received: 08/25/2023; 10/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2021
• 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: OPTISURE.; TENDRIL.
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male