MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ANTHEM RF CRT-P; IMPLANTABLE PACEMAKER

Model Number PM3210

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/07/2020

Event Type  malfunction  

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

It was reported that an asymptomatic patient presented to a follow-up in-clinic with noise over-sensing causing inappropriate automatic mode switch episodes from their pacemaker.Noise was able to be reproduced during isometric exercises.Pacemaker mediated tachycardia was also noted.No intervention was performed and patient was stable after the event.

• Brand Name: ANTHEM RF CRT-P
• Type of Device: IMPLANTABLE PACEMAKER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 10715036
• MDR Text Key: 212450517
• Report Number: 2017865-2020-15930
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 05414734503785
• UDI-Public: 05414734503785
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2014
• Device Model Number: PM3210
• Device Catalogue Number: PM3210
• Device Lot Number: 3814469
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2012
• 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