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

Model Number CDHFA500Q

Device Problems Defective Device (2588); No Pacing (3268)

Patient Problem Arrhythmia (1721)

Event Date 09/15/2023

Event Type  malfunction  

Event Description

Related manufacturer reference number: 2017865-2023-48058.It was reported that the patient presented for implantable cardioverter defibrillator (icd) implant.During the procedure, it was noted that ventricular pacing inhibition occurred upon connection of the leads to the header, resulting in patient asystole.It was further noted that the left ventricular (lv) lead was suspected to have micro-dislodged.Upon reconnection of the leads, it was still noted that there was no low voltage output from the icd.The procedure was completed using an alternate lv lead and icd on (b)(6) 2023.The patient was stable.

Manufacturer Narrative

The reported event of an output, pacing, and header anomaly was not confirmed.Telemetry, impedance, sensing, pacing and high voltage (hv) output functions of the device were tested and found to be normal.No anomalies were found.

• 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: 17892904
• MDR Text Key: 325918700
• Report Number: 2017865-2023-48059
• 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: 12/01/2023

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 Model Number: CDHFA500Q
• Device Lot Number: P000173997
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/17/2023
• Initial Date FDA Received: 10/09/2023
• Supplement Dates Manufacturer Received: 11/10/2023
• Supplement Dates FDA Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2023
• 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: ATRIAL LEAD; NON-SJM RIGHT VENTRICULAR LEAD
• Patient Sex: Male