MAUDE Adverse Event Report: ABBOTT QUARTET; NO MATCH

Model Number 1458Q/86

Device Problems Failure to Capture (1081); High impedance (1291); Therapy Delivered to Incorrect Body Area (1508); Device Dislodged or Dislocated (2923)

Patient Problem Discomfort (2330)

Event Date 08/07/2023

Event Type  Injury  

Event Description

During an in-clinic follow-up, muscle stimulation, high pacing impedance, failure to capture were observed on the left ventricular (lv) lead.X-ray imaging was performed and lv lead dislodgement was observed.The event was resolved by explanting and replacing the lv lead.The patient was in stable condition.

Manufacturer Narrative

The reported events were lead dislodgement, muscle stimulation, high lead impedance, and failure to capture.As received, a complete lead was returned in one piece.Visual inspection of the lead found no anomalies.The s-curve hump height was measured to be within product specification.The reported events of high lead impedance and failure to capture were not confirmed.Electrical testing did not find any indication of conductor fractures or internal shorts.

• 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: 17703427
• MDR Text Key: 322890680
• Report Number: 2017865-2023-42393
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734503198
• UDI-Public: 05414734503198
• Combination Product (y/n): Y
• Reporter Country Code: GM
• 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: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1458Q/86
• Device Lot Number: S000090226
• 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: 10/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2023
• 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 Outcome(s): Required Intervention