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

Model Number PM2172

Device Problem Incorrect Measurement (1383)

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

Event Date 04/06/2023

Event Type  malfunction  

Manufacturer Narrative

Session records were provided for review by technical services.Analysis of the session records indicated that the inaccurate measurements event was sensed by the device.

Event Description

It was reported that during a follow up in clinic, after clearing the diagnostic date on the device an inaccurate longevity estimate was observed.Abbott technical support was contacted, the diagnostic data on the device was again cleared, and the longevity estimate returned to normal.The patient was in stable condition.

• Brand Name: ENDURITY 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 16844574
• MDR Text Key: 314298474
• Report Number: 2017865-2023-18812
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 05414734509602
• UDI-Public: 05414734509602
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: Nurse
• Type of Report: Initial
• Report Date: 05/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Model Number: PM2172
• Device Catalogue Number: PM2172
• Device Lot Number: A000033560
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2016
• 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