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

Model Number PM2240

Device Problems Premature Discharge of Battery (1057); Intermittent Capture (1080)

Patient Problems Arrhythmia (1721); Dyspnea (1816); Fatigue (1849); Dizziness (2194)

Event Date 12/24/2023

Event Type  Injury  

Event Description

Following the electronics performance indicator (epi), an alert was received by the clinician and device was explanted.Device was also exhibiting intermittent capture that led to patient dizziness, pre-syncope, and low heart rates.Doctor elected to place a temporary pacemaker wire on (b)(6) 2023 and then do a full device replacement surgery on (b)(6) 2023.Patient was stable following the replacement procedure.

Event Description

Newly received information noted patient also experienced fatigue due to the pacemaker.

Manufacturer Narrative

Correction: g3 in mdr-2024-01605-01 should have been jan 19, 2024 instead of jan 22, 2024.

• Brand Name: ASSURITY RF DR
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• 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: 18476286
• MDR Text Key: 332448499
• Report Number: 2017865-2024-00753
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734507073
• UDI-Public: 05414734507073
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/06/2024

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: 04/30/2018
• Device Model Number: PM2240
• Device Lot Number: A000031040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/27/2023
• Initial Date FDA Received: 01/09/2024
• Supplement Dates Manufacturer Received: 01/22/2024; 01/29/2024; 02/01/2024
• Supplement Dates FDA Received: 01/22/2024; 01/29/2024; 02/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2016
• 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
• Treatment: 1699TC/46CM OPTISENSE LEAD.; 1888TC/58 LEAD.
• Patient Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Weight: 82 KG