MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ESSENTIO MRI EL DR; IMPLANTABLE DEVICE

Model Number L131

Device Problems Over-Sensing (1438); Under-Sensing (1661)

Patient Problem Dizziness (2194)

Event Date 03/17/2024

Event Type  malfunction  

Event Description

It was reported that technical services (ts) was contacted by the health care professional (hcp) with questions about pacemaker mediated tachycardia (pmt) events.Ts discussed with the hcp that they were false pmt events due to supraventricular tachycardia (svt) oversensing.Undersensing of atrial signals falling into the blanking period was also noted and programming options were discussed.The patient reported feelings of light-headedness and dizziness likely due to their variable heartrate.The device and leads remain in service.No adverse patient effects were reported.

• Brand Name: ESSENTIO MRI EL DR
• Type of Device: IMPLANTABLE DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 19210512
• MDR Text Key: 341371688
• Report Number: 2124215-2024-25980
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526559006
• UDI-Public: 00802526559006
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150012/S000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/06/2018
• Device Model Number: L131
• Device Catalogue Number: L131
• Device Lot Number: 729548
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2016
• 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
• Patient Age: 62 YR
• Patient Sex: Female