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

Model Number PM2172

Device Problems Failure to Disconnect (2541); Separation Failure (2547)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

Further information was requested but not received.The results, method, and conclusion codes along with investigation results will be provided in the final report.

Event Description

During an unrelated lead revision procedure, it was noted that there was difficulty to remove the lead from the header of the device.It was suspected that the cause of the event was due to the device.The device was explanted and replaced to resolve the event.The patient was stable with no consequences.

Manufacturer Narrative

Customer complaint of difficulty to disconnect the lead from the header of the device was not confirmed.Visual inspection on header did not find any anomalies that could cause the complaint in the field.Device was received in normal range of operation.Analysis of device was performed, including noise test, sensitivity test and output measurement which determined no anomalies were noted.Longevity assessment was performed, device was in the normal range of operation with appropriate remaining longevity.

• 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: 10980112
• MDR Text Key: 220654088
• Report Number: 2017865-2020-21997
• 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: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: PM2172
• Device Catalogue Number: PM2172
• Device Lot Number: A000045724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1