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

Model Number CDDRA500Q

Device Problems Over-Sensing (1438); Product Quality Problem (1506)

Patient Problem Insufficient Information (4580)

Event Date 12/28/2020

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 prior to implant procedure, the implantable cardioverter defibrillator appeared to have bubbles in the header.Interrogation revealed oversensing on the atrial channel.The device was not used and no patient was involved.

Manufacturer Narrative

The implantable cardioverter defibrillator was returned for the reported events of bubbles in the header and oversensing on the atrial channel.Analysis confirmed the presence of bubbles, but within manufacturing specification.The atrial oversensing was also confirmed and attributed to the leads not being connected to the device.There was no sensing issue noted on the electrograms.No anomalies were noted.

• Brand Name: GALLANT DR
• 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: 11228295
• MDR Text Key: 228609396
• Report Number: 2017865-2021-06123
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05415067032003
• UDI-Public: 05415067032003
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 04/19/2021

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: 09/30/2022
• Device Model Number: CDDRA500Q
• Device Catalogue Number: CDDRA500Q
• Device Lot Number: S000078565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/31/2020
• Initial Date FDA Received: 01/25/2021
• Supplement Dates Manufacturer Received: 03/26/2021
• Supplement Dates FDA Received: 04/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1