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

Model Number CDHFA500Q

Device Problems Loose or Intermittent Connection (1371); Use of Device Problem (1670); Component Missing (2306)

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

Event Date 02/07/2024

Event Type  malfunction  

Event Description

It was reported that the patient presented for an upgrade procedure.It was noted that when the new can was connected to the right atrial (ra) lead, this was screwed in with no issue but the right ventricular (rv) and left ventricular (lv) lead were unable to be screwed in.There appeared to be no screw in the rv port as the wrench went all the way through and there was too much resistance on the lv port and the lead would not latch on.Multiple hex wrenches were attempted with no success.The new can was exchanged for another.No issues were observed with the replacement.The patient was stable.

Manufacturer Narrative

Correction: product details - serial number, manufacturing date, expiration date, lot #, udi updated/corrected.

Event Description

New information received found the observation to be due to an operator error.The set screw came out with use of the hex wrench by the user.

• 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: 18784134
• MDR Text Key: 336322105
• Report Number: 2017865-2024-33474
• 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: 04/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• 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: P000179135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2023
• 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: DURATA RIGHT VENTRICULAR LEAD; QUARTET LEFT VENTRICULAR LEAD; TENDRIL RIGHT ATRIAL LEAD
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 88 KG