MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ASSURITY MRI; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number PM2272

Device Problems Premature Discharge of Battery (1057); Over-Sensing (1438); No Pacing (3268)

Patient Problems Arrhythmia (1721); Bradycardia (1751); Complete Heart Block (2627)

Event Date 12/01/2020

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Related manufacturer reference number: 2017865-2020-23029, 2017865-2020-23030.It was reported that the patient was in complete heart block and showed to the emergency room with no pacing and an escape rate around 40 beats per minute.The physician wondered whether there was a current drain that was causing the lack of pacing and leading to complete heart block.The physician was also unsure whether there was oversensing issues due to programming or due to the device.There was no evidence of oversensing due to programming, and oversensing could not be reproduced.The physician elected to explant everything.The pacemaker system was explanted and replaced.The patient was stable post-procedure.

Manufacturer Narrative

An evaluation performed on the device¿s header did not find any anomaly that could contribute to the capture complaint.Electrical and mechanical analysis performed, including capture test under nominal settings, indicated normal device functionality.The battery is within the normal range of operation.A longevity assessment was performed, and the device was in the normal range of operation with appropriate remaining longevity.

• Brand Name: ASSURITY MRI
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 11024460
• MDR Text Key: 221991232
• Report Number: 2017865-2020-23028
• 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,health
• Type of Report: Initial,Followup
• Report Date: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: PM2272
• Device Catalogue Number: PM2272
• Device Lot Number: A000076541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ISOFLEX OPTIM LEAD; TENDRIL STS; ISOFLEX OPTIM LEAD; TENDRIL STS
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR