MAUDE Adverse Event Report: ABBOTT QUARTET; NO MATCH

Model Number 1458Q/86

Device Problems Failure to Capture (1081); Use of Device Problem (1670)

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

Event Date 08/14/2023

Event Type  malfunction  

Event Description

During an implant procedure, the left ventricular (lv) lead was having difficulty being implanted with the provided connector sleeve.Furthermore, a high capture threshold resulting in a loss of capture was observed on the lv lead.The lv lead was explanted and replaced to resolve the event.The patient was stable.

Manufacturer Narrative

The reported events of failure capture and difficulty when securing the lead into the device connector were not confirmed.As received, a complete lead was returned in one piece for analysis without the connector sleeve for evaluation.Electrical testing did not find any indication of conductor fractures or internal shorts.The lead connector passed insertion testing into the test icd device and is-4 connector sleeve.Dimensional analysis of the connector boot was measured within the product specifications.Visual and x-ray inspections of the lead did not find any anomalies.A review of the device history record (dhr) confirmed that no issues were identified related to this reported event.

• Brand Name: QUARTET
• Type of Device: NO MATCH
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 17647646
• MDR Text Key: 322250840
• Report Number: 2017865-2023-40646
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734503198
• UDI-Public: 05414734503198
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1458Q/86
• Device Lot Number: S000089731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2023
• 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