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

Model Number CD3367-40C

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930)

Event Date 08/01/2019

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.Further information was requested but not received.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer reference number: 2017865-2019-12377.It was reported that the patient had re-implantation procedure on (b)(6) 2019 after system was explanted due to recurrent infection in (b)(6) 2019, the implantable cardioverter defibrillator was sterilized and re-implanted and a new lead was implanted.On (b)(6) 2019 the patient presented for wound check.Pus was noted in the pocket are in the abdomen.The physician suspects that the patient might have developed sensitivity/allergy towards the device and lead materials.The physician would consult a dermatologist to do the patch testing on the patient.No device intervention occurred.Patient was stable and will continue to be monitored.

Manufacturer Narrative

Additnaiol information: event, if follow-up, what type.

Event Description

New information received noted that the patient was not sensitive/allergic to the device or leads.

• Brand Name: QUADRA ASSURA ICD
• 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: 8899061
• MDR Text Key: 154486447
• Report Number: 2017865-2019-12376
• Device Sequence Number: 1
• Product Code: NIK
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/12/2019

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: 04/30/2019
• Device Model Number: CD3367-40C
• Device Lot Number: S000033966
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/01/2019
• Initial Date FDA Received: 08/15/2019
• Supplement Dates Manufacturer Received: 08/28/2019
• Supplement Dates FDA Received: 09/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: QUARTET; QUARTET
• Patient Outcome(s): Required Intervention