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

Model Number CDVRA500Q

Device Problem Loose or Intermittent Connection (1371)

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

Event Type  malfunction  

Event Description

Related manufacturing reference number: 2017865-2023-72696.It was reported that the patient presented for a follow up in clinic.It was noted that the right ventricular (rv) lead had high capture thresholds and device sensing issues in the form of r-wave amplitude variation.It was discovered via fluoroscopy that the rv lead was dislodged.The patient was asymptomatic.The helix failed to retract while the physician was trying to reposition the rv lead.Another rv lead was used, but while connecting it to the existing implantable cardioverter defibrillator (icd), it was discovered that the set screw was stripped.The icd was also replaced.A new rv lead and icd was successfully implanted.The patient was stable throughout the procedure.

Manufacturer Narrative

Corrected data: b5 updated to show the helix of the right ventricular (rv) lead failed to extend rather than retract.

Event Description

Correction: the helix of the right ventricular (rv) lead failed to extend, but it could retract.

• Brand Name: GALLANT VR
• 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: 18171695
• MDR Text Key: 328550726
• Report Number: 2017865-2023-72695
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05415067031990
• UDI-Public: 05415067031990
• 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,Followup
• Report Date: 02/05/2024

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: CDVRA500Q
• Device Lot Number: A000146862
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/07/2023
• Initial Date FDA Received: 11/20/2023
• Supplement Dates Manufacturer Received: 11/07/2023; 02/05/2024
• Supplement Dates FDA Received: 11/21/2023; 02/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2023
• 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: 63 YR
• Patient Sex: Female