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

Model Number PM2240

Device Problem Under-Sensing (1661)

Patient Problems Syncope (1610); Chest Pain (1776)

Event Date 10/12/2020

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.Serial number, model number, manufacturing date, expiration date, physical manufacturing site, udi, implant date, patient name and date of birth are unknown.

Event Description

It was reported that the patient presented to the hospital after experiencing a syncopal episode.Upon interrogation, it was noted that the pacemaker undersensed an episode of high ventricular rate.The episode terminated and the device began pacing normally.No intervention was reported.The patient was in stable condition and will continue to be monitored.

Event Description

New information notes that the patient also experienced chest pain.

• Brand Name: ASSURITY
• 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: 10774675
• MDR Text Key: 214367150
• Report Number: 2017865-2020-16975
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• PMA/PMN Number: P880086
• 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: 11/24/2020

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: 10/31/2016
• Device Model Number: PM2240
• Device Catalogue Number: PM2240
• Device Lot Number: A000005530
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 11/02/2020
• Supplement Dates Manufacturer Received: 10/13/2020; 11/10/2020
• Supplement Dates FDA Received: 11/06/2020; 11/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR