MAUDE Adverse Event Report: QUARTET LEAD SMALL-S, 86 CM; No Match

Model Number 1456Q/86

Device Problems Failure to Capture (1081); Device Dislodged or Dislocated (2923)

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

Event Date 01/30/2024

Event Type  Injury  

Event Description

During an in-clinic follow-up, failure to capture was observed on the left ventricular (lv) lead.The cause of the event is due to dislodgement which was confirmed with diagnostic imaging.The lead was explanted and replaced the resolve the event.The patient was stable.

• Brand Name: QUARTET LEAD SMALL-S, 86 CM
• Type of Device: No Match
• MDR Report Key: 18717334
• MDR Text Key: 335521729
• Report Number: 2017865-2024-22505
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): Y
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Type of Report: Initial
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: 1456Q/86
• Device Lot Number: A000099131
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2020
• 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 STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR.; NEUTRINO NXT HF.; TENDRIL STS.
• Patient Outcome(s): Required Intervention