MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ESSENTIO DR; IMPLANTABLE PACEMAKER

Model Number L101

Device Problem Pacing Problem (1439)

Patient Problems Tachycardia (2095); Syncope/Fainting (4411)

Event Date 08/24/2022

Event Type  Injury  

Manufacturer Narrative

This investigation will be updated should further pertinent information be provided.

Event Description

It was reported that this pacemaker recorded a pacemaker mediated tachycardia (pmt) episode which was ended with algorithm appropriately.All measurements where within normal limits.The patient also reported a syncopal episode but the pmt episode does not correlate with the time the patient experienced the syncope.Several weeks later, the patient experienced a pmt episode again and passed out around the same time.The pacemaker showed no out of range measurements and the rhythm appears atrial or sinus drive.The pacemaker remains in service.No additional adverse patient effects were reported.

• Brand Name: ESSENTIO DR
• Type of Device: IMPLANTABLE PACEMAKER
• 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: 15549166
• MDR Text Key: 301237272
• Report Number: 2124215-2022-40011
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526558924
• UDI-Public: 00802526558924
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N970003/S167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/06/2022

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: Lay User/Patient
• Device Expiration Date: 08/17/2019
• Device Model Number: L101
• Device Catalogue Number: L101
• Device Lot Number: 762547
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/18/2022
• Initial Date FDA Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2017
• 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
• Patient Age: 100 YR
• Patient Sex: Female