MAUDE Adverse Event Report: ABBOTT QUARTET; PERMANENT PACEMAKER ELECTRODE

Model Number 1458

Device Problems High impedance (1291); Device Dislodged or Dislocated (2923); No Apparent Adverse Event (3189); Insufficient Information (3190)

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

Event Date 05/21/2021

Event Type  malfunction  

Manufacturer Narrative

Further information was requested but not received.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

During an in clinic follow-up, the device gave a vibratory alert for the left ventricular (lv) lead.The cause of the vibratory alert was unknown.Further information was requested but has not been received.The device was reprogrammed to resolve the event.The patient was in stable condition.

Event Description

Additional information received indicated the vibratory alert was given due to high pacing impedance on the left ventricular (lv) lead.The lv lead was suspected to have become dislodged, however, no dislodgement could be confirmed via x-ray imaging.After reprogramming, another vibratory alert was given by the device.No further intervention was performed at this time.The patient was stable and will continue to be monitored.

Manufacturer Narrative

Correction: manufacturing report 2017865-2021-20402 should not have been reported as a medical device report (mdr) as there is no indication that the device was manufactured by abbott.

• Brand Name: QUARTET
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 11939176
• MDR Text Key: 254298877
• Report Number: 2017865-2021-20402
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): N
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1458
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1