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

Model Number CD3369-40Q

Device Problems High impedance (1291); Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/26/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during the implant procedure there was an attempt to insert a lead into the header of the implantable cardioverter defibrillator.The resulting lead impedance was out of range.The lead was wiped clean and reinserted, yet the issue persisted.It was noted that the lead was unable to advance past the ring of the device header.The lead was easily placed into the replacement generator.The physician alleged there was a header defect.The patient was stable.

Manufacturer Narrative

The reported field event of a header anomaly was confirmed.Test leads were unable to be inserted into the lv chamber.The cause was found to be due to a metal burr found in the spring groove of the lv chamber.Manufacturing investigation was performed.It could not be confirmed that the source of the foreign material was part of the manufacturing process.The root cause was undetermined.

• Brand Name: QUADRA ASSURA MP 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: 9182742
• MDR Text Key: 162083534
• Report Number: 2017865-2019-14314
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734508377
• UDI-Public: 05414734508377
• Combination Product (y/n): N
• PMA/PMN Number: P910023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: CD3369-40Q
• Device Catalogue Number: CD3369-40Q
• Device Lot Number: A000079041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/26/2019
• Initial Date FDA Received: 10/11/2019
• Supplement Dates Manufacturer Received: 01/05/2021
• Supplement Dates FDA Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 74