MAUDE Adverse Event Report: ABBOTT QUICKSITE LV; PERMANENT PACEMAKER ELECTRODE

Model Number 1056T/86

Device Problems Signal Artifact/Noise (1036); Break (1069); Failure to Capture (1081); Impedance Problem (2950)

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

Event Date 02/23/2023

Event Type  malfunction  

Event Description

It was reported that during the follow up in clinic, noise and varying low voltage impedance was noted on the left ventricular (lv) lead.Provocative testing was performed and the noise and varying low voltage impedance was able to be reproduced.The physician suspected lv lead damage, however, diagnostic imaging was not performed.No intervention has been performed at this time.The patient was in stable condition and will continue to be monitored.

Manufacturer Narrative

Session records were provided for review by technical services.Analysis of the session records indicated that the noise event was sensed by the device.

Event Description

Additional information was received indicating loss of capture was noted on the left ventricular (lv) lead.Diagnostic imaging was performed and no anomalies were observed.No intervention was performed.The patient was in stable condition and will continue to be monitored.

• Brand Name: QUICKSITE LV
• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 16564865
• MDR Text Key: 311502218
• Report Number: 2017865-2023-14000
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): N
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2009
• Device Model Number: 1056T/86
• Device Lot Number: 2965035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2006
• 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