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

Model Number CD3365-40Q

Device Problem Failure to Convert Rhythm (1540)

Patient Problems Ventricular Fibrillation (2130); Ventricular Tachycardia (2132)

Event Date 10/01/2019

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

Related manufacturer reference number: 2938836-2019-14570.It was reported that when the patient presented to the clinic on (b)(6) 2019 for a non-invasive program stimulations (nips) procedure, the physician induced a ventricular tachycardy (vt) which degenerated to ventricular fibrillation (vf).The device appropriately detected the vf and delivered two high voltage shocks which both failed to convert the patient to sinus rhythm.The patient was successfully defibrillated with an external shock.Fluoroscopy was performed and revealed that the right ventricular lead was positioned high in the septum.The physician elected to revise the lead.The patient presented to the clinic on (b)(6) 2019 where the single coil lead was capped and replaced with a dual coil lead.Following the procedure, defibrillation threshold testing (dft) was performed which also failed to convert the patient to sinus rhythm.The patient was successfully defibrillated with external shocks.The patient presented to the clinic on (b)(6) 2019 where an azygous competitor lead was implanted with an adapter to connect with the dual coil lead.The implantable cardioverter defibrillator was explanted and replaced with a new device.The patient was stable.

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

New information received notes that the implantable cardioverter defibrillator was electively explanted and replaced since it may reach elective replacement indicator (eri) in 18 months or less and the patient would not need to have additional procedure by then.The patient's condition was stable following the procedure.

Manufacturer Narrative

Analysis was normal.No anomalies were found.

• Brand Name: QUADRA ASSURA CRT-D QUAD RF HV
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• 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: 9195078
• MDR Text Key: 162491559
• Report Number: 2938836-2019-15159
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734508292
• UDI-Public: 05414734508292
• 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,Followup
• Report Date: 02/14/2020

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: 02/28/2018
• Device Model Number: CD3365-40Q
• Device Catalogue Number: CD3365-40Q
• Device Lot Number: A000018271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/01/2019
• Initial Date FDA Received: 10/15/2019
• Supplement Dates Manufacturer Received: 10/16/2019; 02/07/2020
• Supplement Dates FDA Received: 11/02/2019; 02/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Weight: 130