MAUDE Adverse Event Report: ABBOTT QUICKFLEX MICRO LV LEAD; PERMANENT PACEMAKER ELECTRODE

Model Number 1258T/86

Device Problems Failure to Capture (1081); High impedance (1291); Failure to Sense (1559); Capturing Problem (2891); Device Dislodged or Dislocated (2923)

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

Event Type  Injury  

Manufacturer Narrative

Further information was requested but not received.

Event Description

Related manufacturer report number: 2017865-2022-01079 and 2017865-2022-01081.During an in clinic follow up, an increased threshold, high pacing impedance and a loss of sensing was noted on the right ventricular (rv) and left ventricular (lv) leads.An x-ray was performed and revealed dislodgement of both the rv and lv leads.The rv lead was explanted and replaced.The lv lead was explanted and during the replacement of the lv lead, it was noted the guidewire was unable to advance in the new lv lead.The lv lead was explanted and replaced to resolve the event.The patient was stable.

Event Description

Additional information was received indicating the increased threshold resulted in a loss of capture.

Manufacturer Narrative

The reported events were lead dislodgement, high pacing impedance, failure to sense and failure to capture.As received, a complete lead was returned in one piece.The reported events of high pacing impedance, failure to sense and failure to capture were not confirmed.Visual examination of the lead did not find any anomalies with the exception of procedural damage.Electrical testing did not find any indication of conductor fractures or internal shorts.S-curve was measured to be within specification.

• Brand Name: QUICKFLEX MICRO LV LEAD
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 13251403
• MDR Text Key: 283761961
• Report Number: 2017865-2022-01080
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 05414734502610
• UDI-Public: 05414734502610
• 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,Followup
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 1258T/86
• Device Catalogue Number: 1258T-86
• Device Lot Number: A000095140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2020
• 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; QUICKFLEX MICRO LV LEAD
• Patient Outcome(s): Required Intervention