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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 11/26/2018

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

It was reported patient presented six to eight months ago with a draining boil and was resolved using triple antibiotic ointment.On (b)(6) 2018 during a clinic visit, patient had focal chest pain on top of the same area, which is the course of one of the leads.Patient was given two-week prescription of keflex then presented back in clinic on (b)(6) 2018.On that day the physician determined that area was an infection and an inflammatory reaction due to the cardiac device.System extraction and reimplantation on the right side of chest was discussed.No further information available.

Event Description

New information received notes the leads could be felt under the skin¿s surface and physician decided it would be best to explant the entire system.On (b)(6) 2019 the system was explanted.The patient was stable before, during, and after the procedure.A temporary right ventricular lead was placed and attached to the explanted device until the patient could be reimplanted.On (b)(6) 2019 a new system was implanted.Patient was stable before, during, and after 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: 8197149
• MDR Text Key: 131425791
• Report Number: 2938836-2018-13322
• 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: 03/20/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2015
• Device Model Number: CD3365-40Q
• Device Catalogue Number: CD3365-40Q
• Device Lot Number: 4265552
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/10/2018
• Initial Date FDA Received: 12/26/2018
• Supplement Dates Manufacturer Received: 01/09/2019; 03/05/2019
• Supplement Dates FDA Received: 01/23/2019; 03/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2013
• 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: MODEL: 1458Q/86 SERIAL: (B)(4); MODEL: 7120Q/58 SERIAL: (B)(4)
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 79 YR