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

Model Number PM2272

Device Problems Signal Artifact/Noise (1036); Electromagnetic Interference (1194); Over-Sensing (1438)

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

Event Date 09/20/2020

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: 2017865-2020-15017.It was reported that the patient presented remotely via merlin.Net.Review of transmissions revealed that the right ventricular lead exhibited false high ventricular rate episodes due to oversensing of electrical noise.It was noted that the noise was reproducible by tapping on the pacemaker and some pacing inhibition was present.Electromagnetic interference was suspected.No device intervention was performed and the patient will be monitored.The patient was stable.

Event Description

Related manufacturer reference number: 2017865-2020-21830.New information notes that the physician also alleged noise oversensing that led to pacing inhibition on the atrial lead.The physician explanted and replaced the dual chamber pacing system.The patient was stable.

Manufacturer Narrative

The reported field event of noise was not confirmed in the laboratory.The device was tested on the bench and using automated testing equipment, and no anomalies were found.

• 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: 10681995
• MDR Text Key: 211424183
• Report Number: 2017865-2020-15018
• 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,Followup
• Report Date: 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: PM2272
• Device Catalogue Number: PM2272
• Device Lot Number: A000094041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TENDRIL STS; TENDRIL STS; TENDRIL STS
• Patient Outcome(s): Required Intervention