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

Model Number CDDRA500Q

Device Problem Data Problem (3196)

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

Event Date 12/10/2021

Event Type  malfunction  

Event Description

Related manufacturer reference number: 2017865-2021-40542.It was reported during capture threshold testing, the user released the button to terminate the testing on the merlin programmer as expected, however, the patient's implantable cardioverter-defibrillator continued to decrement, resulting in loss of capture.No interventions were reported.The patient was stable.

Event Description

It was reported that the patient presented in clinic after a parameter-out-of-range alert was seen on the implantable cardioverter defibrillator (icd).Upon interrogation, it did not appear that the error message was resolved and it was determined the invalid diagnostic issue could only be resolved with the future software release.Then, during capture threshold testing, the user released the button to terminate the testing on the merlin programmer as expected, but the capture test did not terminate and continued to decrement.The patient did not experience any symptoms due to this event.When the capture testing was repeated, it was completed without difficulty.No interventions were performed.The patient was in stable condition.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 13122763
• MDR Text Key: 283146671
• Report Number: 2017865-2021-40541
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05415067032003
• UDI-Public: 05415067032003
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: CDDRA500Q
• Device Catalogue Number: CDDRA500Q
• Device Lot Number: S000083860
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2021
• 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: 2088TC/52 TENDRIL STS ATRIAL LEAD; LDA210Q/58 OPTISUREMRI RIGHT VENTRICULAR LEAD
• Patient Age: 61 YR
• Patient Sex: Male