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

Model Number PM2272

Device Problem Pacing Intermittently (1443)

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

Event Date 05/23/2022

Event Type  malfunction  

Event Description

Related manufacturer report number: 2017865-2022-11384, 2017865-2022-11385.During an in clinic follow-up, low sensing and high capture threshold were observed on the right ventricular (rv) and right atrial (ra) leads.The rv and ra leads were explanted and replaced to resolve the event.After the physician connected new leads, intermittent pacing was observed on the device.The patient was not pacemaker dependent and the device was explanted and replaced to resolve the event.The patient was in stable condition.

Manufacturer Narrative

The reported event of intermittent pacing were not confirmed.Upon receipt, the device was in normal range of operation.The device image was analyzed and the average monthly voltage and current trends were normal.A visual analysis was performed on the header and no anomalies were observed.Additionally, telemetry, output and pacing function testing was performed and no anomalies were revealed.A longevity assessment was performed and device had appropriate longevity remaining.

• Brand Name: ASSURITY MRI
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• 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: 14634317
• MDR Text Key: 293942115
• Report Number: 2017865-2022-11382
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 05414734509589
• UDI-Public: 05414734509589
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P140033
• 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
• Report Date: 08/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: PM2272
• Device Catalogue Number: PM2272
• Device Lot Number: P000137615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2021
• 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