MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) GALLANT VR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CDVRA500Q

Device Problem Delayed Charge Time (2586)

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

Event Type  malfunction  

Manufacturer Narrative

Further information was requested, but not received.

Event Description

It was reported that a patient presented with long changed time noted on the patient's implantable cardioverter defibrillator.No intervention or adverse patient consequences were reported.

Manufacturer Narrative

Codes should reflect product not returned.

• Brand Name: GALLANT VR
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• 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: 17012527
• MDR Text Key: 316665315
• Report Number: 2017865-2023-21225
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/14/2023

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: CDVRA500Q
• Device Catalogue Number: CDVRA500Q
• Device Lot Number: S000088478
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/11/2023
• Initial Date FDA Received: 05/26/2023
• Supplement Dates Manufacturer Received: 12/14/2023
• Supplement Dates FDA Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2022
• 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: DURATALEADS
• Patient Age: 84 YR
• Patient Sex: Female