MAUDE Adverse Event Report: ABBOTT QUADRA ALLURE MP RF CRT-P; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number PM3262

Device Problems Over-Sensing (1438); No Pacing (3268)

Patient Problems Syncope (1610); Fall (1848); Dizziness (2194); Syncope/Fainting (4411)

Event Date 10/10/2020

Event Type  Injury  

Manufacturer Narrative

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

Related manufacturer reference number: 2017865-2020-17193 and 2017865-2020-17194.During a clinic follow-up, a loss of pacing and episodes of oversensing were observed on the device and a low pacing impedance, loss of capture, and episodes of high ventricular rate due to noise resulting in oversensing and pacing inhibition were observed on the right ventricular (rv) lead.It is unknown if the oversensing and loss of pacing was due to the device or the rv lead, but the patient is pacemaker dependent and experienced falls as a result.Furthermore, a low pacing impedance was observed on the right atrial (ra) lead.Technical support was contacted and the device was reprogrammed to resolve the event.The patient was stable and will continue to be monitored.

Event Description

Additional information was received that the patient experienced dizziness, resulting in the patient falls.

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Additional information was received that the patient experienced syncope due to the device or the right ventricular (rv) lead.Furthermore, both the device and the rv lead were explanted and replaced to resolve the event.Additionally, during the revision procedure, the right atrial (ra) lead was also explanted and replaced.The patient was stable and will continue to be monitored.

Manufacturer Narrative

Additional information: d9, h3, and h6 the reported events of pacing, capture, and sensing issues were not confirmed.The device was received at a normal range of operation with telemetry working appropriately.Functional analysis of the device was performed, including output monitoring, capture, and sensitivity tests, and no issues were revealed.Visual inspection of the atrial, right ventricular, and left ventricular channels did not reveal any anomalies that would cause the anomalies that were seen in the field.A longevity assessment was performed and the device was in the normal range of operation with appropriate remaining longevity.

• Brand Name: QUADRA ALLURE MP RF CRT-P
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 10793062
• MDR Text Key: 214815306
• Report Number: 2017865-2020-17190
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734509091
• UDI-Public: 05414734509091
• Combination Product (y/n): N
• PMA/PMN Number: P030035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: PM3262
• Device Catalogue Number: PM3262
• Device Lot Number: P000026653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ABBOTT RIGHT ATRIAL LEAD; LOW VOLTAGE RV LEAD; ABBOTT RIGHT ATRIAL LEAD; LOW VOLTAGE RV LEAD
• Patient Outcome(s): Other; Required Intervention