MAUDE Adverse Event Report: ABBOTT ASSURITY MRI; Implantable pulse generator, pacemaker (non-CRT)

Model Number PM1272

Device Problem Incorrect Measurement (1383)

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

Event Date 02/29/2024

Event Type  malfunction  

Event Description

It was reported that a diagnostic anomaly resulting in a false elective replacement indicator (eri) alert was observed on the device.Abbott technical support was alleged the event was due to lack of data for the device longevity calculation as a result of programming the implant date into the device the same day of the interrogation.No intervention was performed as the event resolved itself after the device gathered more data.The patient was in stable condition and will continue to be monitored.

• Brand Name: ASSURITY MRI
• Type of Device: Implantable pulse generator, pacemaker (non-CRT)
• 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: 18979860
• MDR Text Key: 338617766
• Report Number: 2017865-2024-36916
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 05414734509572
• UDI-Public: 05414734509572
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PM1272
• Device Lot Number: P000185078
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2023
• 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