MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) GALLANT HF; NO MATCH

Model Number CDHFA500Q

Device Problems Over-Sensing (1438); Failure to Convert Rhythm (1540); Defibrillation/Stimulation Problem (1573); Inappropriate or Unexpected Reset (2959)

Patient Problems Arrhythmia (1721); Dyspnea (1816); Fatigue (1849); Dizziness (2194); Discomfort (2330); Syncope/Fainting (4411)

Event Date 08/15/2023

Event Type  Injury  

Event Description

It was reported that a patient presented with bvvi mode noted on the patient's implantable cardioverter defibrillator.While corrective programming changes were being made, the patient reported lightheadedness, fatigue, and heart palpitations with discomfort.Following completion of the programming changes, the patient went into ventricular fibrillation, resulting in syncope and loss of consciousness.Anti tachycardia pacing was delivered but was not successful in converting the rhythm.The device reverted to bvvi mode and the patient's symptoms were resolved.It was suspected that the patient had become bradycardic or the device was over-sensing noise, so the device was explanted and replaced on (b)(6) 2023.No further adverse consequences were reported and the patient was stable.

Manufacturer Narrative

The reported event of sensing noise was confirmed.External noise was confirmed and resulted in oversensing.The device appears to behave as programmed.The reported event of high voltage output issue was not confirmed.The reported event of backup operation was confirmed.Analysis of device image found the device went into backup mode due to memory error.After the device was restored from backup mode, functional testing was performed.Telemetry, impedance, sensing, pacing and high voltage (hv) output functions of the device were tested and found to be normal.The backup operation could not be reproduced.The cause of the reported event could not be determined.

• Brand Name: GALLANT HF
• Type of Device: NO MATCH
• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 17705262
• MDR Text Key: 322924602
• Report Number: 2017865-2023-42312
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05415067032010
• UDI-Public: 05415067032010
• 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: 11/29/2023

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: CDHFA500Q
• Device Lot Number: S000083472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/07/2023
• Supplement Dates Manufacturer Received: 11/17/2023
• Supplement Dates FDA Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2021
• 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: DURATAACTIVE; QUARTETLEADS; TENDRILLEADS
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 136 KG
• Patient Race: White