MAUDE Adverse Event Report: ABBOTT ENDURITY MRI; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number PM2172

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Cardiac Tamponade (2226); Discomfort (2330); Pericardial Effusion (3271)

Event Date 11/03/2020

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

The patient presented to the hospital with symptoms of thoracic pain, sweating, dry mouth, and dyspnea and a pericardial effusion resulting in cardiac tamponade was noted.It was unknown if the atrial lead, device, or implant procedure caused or contributed to the pericardial effusion and cardiac tamponade.The patient was hospitalized, however, no intervention was performed apart from medication administration.The patient was discharged from the hospital and was in stable condition.Related manufacturer report number: 2017865-2020-17813.

Event Description

Additional information was received indicating the patient continued to experience a worsening pericardial effusion and cardiac tamponade.They also experienced a pleural effusion.The patient was hospitalized and pericardiocentesis was performed to resolve the event.The patient was stable.

• Brand Name: ENDURITY MRI
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 10846078
• MDR Text Key: 216561014
• Report Number: 2017865-2020-17596
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 05414734509602
• UDI-Public: 05414734509602
• Combination Product (y/n): N
• PMA/PMN Number: P140033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: PM2172
• Device Catalogue Number: PM2172
• Device Lot Number: P000100367
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2088TC/52, CNY770939; 2088TC/52, CNY770939
• Patient Outcome(s): Hospitalization; Other