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

Model Number CDDRA500Q

Device Problems Incorrect Measurement (1383); Communication or Transmission Problem (2896)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/10/2021

Event Type  malfunction  

Event Description

It was reported that the patient presented in clinic for a novel device implant procedure.While performing the manual atrial threshold test after the procedure, it was found that the novel implantable cardioverter defibrillator exhibited a programming anomaly which resulted in the atrial threshold starting at a lower value than expected.No intervention was performed.The patient was stable.

Manufacturer Narrative

Correction: g3- previously submitted reportable awareness date should have been 16 jun 2021 rather than left blank.

Manufacturer Narrative

The reported event of threshold anomaly was confirmed.Analysis of externally provided device diagnostics found a software error resulting in the diagnostic anomaly.No other issues were found.

• 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: 11400315
• MDR Text Key: 234321085
• Report Number: 2017865-2021-10888
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/17/2021

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: 12/31/2022
• Device Model Number: CDDRA500Q
• Device Catalogue Number: CDDRA500Q
• Device Lot Number: P000114793
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/10/2021
• Initial Date FDA Received: 03/02/2021
• Supplement Dates Manufacturer Received: 06/16/2021; 06/16/2021
• Supplement Dates FDA Received: 06/17/2021; 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 89 YR