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

Model Number PM2272

Device Problems Pacing Problem (1439); Incorrect Interpretation of Signal (1543); Capturing Problem (2891)

Patient Problem Arrhythmia (1721)

Event Date 11/15/2022

Event Type  Injury  

Event Description

It was reported that an asymptomatic patient presented to the clinic on (b)(6) 2022 for a routine follow up.Upon interrogation, it was noted that a high ventricular rate (hvr) episode on (b)(6) 2022 appeared to exhibit two instances of suspected proarrhythmia as a result of their pacemaker.Two episodes of onset ventricular tachycardia were shown to immediately follow backup pulses delivered due by the autocapture feature, indicating inappropriate capture.Programming changes were made to turn autocapture off, and the patient was stable throughout.

Manufacturer Narrative

Correction - h6 - medical device problem code of "1543 - incorrect interpretation of signal" should not have been included in initial report from 29 nov 2022.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 15877561
• MDR Text Key: 304432779
• Report Number: 2017865-2022-47012
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 05414734509589
• UDI-Public: 05414734509589
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P140033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: PM2272
• Device Catalogue Number: PM2272
• Device Lot Number: P000086501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/17/2022
• Initial Date FDA Received: 11/29/2022
• Supplement Dates Manufacturer Received: 01/05/2023
• Supplement Dates FDA Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2019
• 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
• Patient Outcome(s): Other