MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ASSURA CRT-D QUAD RF HV; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3365-40Q

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Complete Heart Block (2627)

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

Related manufacturer reference number: 2017865-2020-17011, 2017865-2020-17012, 2017865-2020-17013.It was reported that the patient presented in clinic for a prophylactic replacement of possibly an infected left-sided cardiac resynchronization therapy defibrillator (crt-d) system.The patient reportedly had a transfer from another institution where he was observed for sepsis, possibly emanating from the leads in the crt-d system or from a since replaced peripherally inserted central catheter (picc) line.It was concluded that full system extraction was necessary as the sepsis had not abated while the patient was undergoing antibiotic therapy.Pre-procedure system measurements revealed no abnormalities.During the extraction process, the patient experienced complete heart block, and when venous access couldn¿t be obtained, a femoral access and temporary pacing line was deployed to support the patient for the remainder of the procedure.Full extraction was successful, and a new, right-sided crt-d was implanted with optimal test results obtained.The patient was stable.

Manufacturer Narrative

Additional information: h6.

Manufacturer Narrative

Interrogation of the device revealed it was above eri when received.Based on this information, the device was found to communicate appropriately with a merlin programmer and has not reached the elective replacement indicator (eri).

• Brand Name: QUADRA ASSURA CRT-D QUAD RF HV
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 10775987
• MDR Text Key: 214297450
• Report Number: 2017865-2020-17010
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734508292
• UDI-Public: 05414734508292
• Combination Product (y/n): N
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: CD3365-40Q
• Device Catalogue Number: CD3365-40Q
• Device Lot Number: A000008036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR; OPTISENSE LEAD; QUARTET; DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR; OPTISENSE LEAD; QUARTET
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 77