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

Model Number CDHFA500Q

Device Problems Failure to Capture (1081); High impedance (1291); Loose or Intermittent Connection (1371)

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

Event Date 02/02/2024

Event Type  malfunction  

Event Description

Related manufacturing reference number: 2017865-2024-33189 related manufacturing reference number: 2017865-2024-33191 it was reported that the left ventricular lead exhibited loss of capture.Dislodgement was confirmed via x-ray.The physician decided to revise the lead.When the physician attempted to reposition the lead, it was noted the guidewire was unable to advance through the lead.The lead was explanted and replaced.When the new lead was plugged into the chronic implantable cardioverter defibrillator (icd), it was noted there was loss of capture, high pacing impedance, and the set screw had stripped.The icd was removed and replaced.When the new icd was implanted, it was noted the set screw on the right ventricular header could not be removed.The icd was removed and replaced successfully.The patient was stable.

Manufacturer Narrative

The reported event of set screw anomaly was confirmed.Final analysis found the device was above the elective replacement indicator (eri) upon receipt.Analysis revealed the left ventricular septum was damaged during procedure and the set screw was unseated.The set screw anomaly was consistent with having occurred during the procedure.The reported event of capture and high pacing lead impedance could not be confirmed.Telemetry, impedance, sensing, pacing and high voltage (hv) output functions of the device were tested and found to be normal.During analysis, a failure event was observed which was unrelated to the reported event.Final analysis found that the header was partially opaque.

• 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: 18751525
• MDR Text Key: 335901235
• Report Number: 2017865-2024-33190
• Device Sequence Number: 1
• Product Code: NIK
• 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: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• 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: S000091671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2023
• 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
• Patient Age: 51 YR
• Patient Sex: Female