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

Model Number PM2272

Device Problem Separation Failure (2547)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/11/2020

Event Type  malfunction  

Manufacturer Narrative

The results, method, and conclusion codes along with investigation results will be provided in the final report.

Event Description

During a device upgrade procedure, the leads were unable to be removed from the device header after loosening the set screws.The header was taken apart to separate the leads from the device.The patient was in stable condition following the procedure.

Manufacturer Narrative

Additional information: d10, h3, h6 the reported event of unable to remove the right atrial lead and right ventricular lead from the device header was not confirmed.The header was broken apart with only pieces of it returned.No foreign material or anomalies were noted in the pieces that would cause the inability to remove the leads from the header.No further analysis could be performed due to the damage to the header and an insufficient portion of the header was returned from the field to make an evaluation of the problem.Furthermore, the device battery voltage was above elective replacement indicator (eri) level.

• Brand Name: ASSURITY MRI
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 10089263
• MDR Text Key: 192058264
• Report Number: 2017865-2020-06599
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 05414734509589
• UDI-Public: 05414734509589
• 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: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: PM2272
• Device Catalogue Number: PM2272
• Device Lot Number: P000055536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/11/2020
• Initial Date FDA Received: 05/26/2020
• Supplement Dates Manufacturer Received: 08/17/2020
• Supplement Dates FDA Received: 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1