MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACCOLADE EL DR; IMPLANTABLE PULSE GENERATOR (PACEMAKER)

Model Number L321

Device Problems Failure to Capture (1081); Pacing Problem (1439); Under-Sensing (1661)

Patient Problem Asystole (4442)

Event Date 12/06/2022

Event Type  malfunction  

Event Description

It was reported that this implantable pulse generator (pacemaker) has showed intermittent right ventricular loss of capture and intermittent right atrial undersensing during a pacemaker mediated tachycardia (pmt) and other atrial fibrillation episodes.The pmt episode shows over 2 seconds of a ventricular pause.Technical services reviewed the case, indicated that the current programming is not adequate for the patient and subsequently recommended to reprogram this pacemaker to mitigate these issues from reoccurring.This pacemaker remains in service and no additional adverse patient effects were reported.

• Brand Name: ACCOLADE EL DR
• Type of Device: IMPLANTABLE PULSE GENERATOR (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: 15977862
• MDR Text Key: 307929725
• Report Number: 2124215-2022-52635
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526559242
• UDI-Public: 00802526559242
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/10/2018
• Device Model Number: L321
• Device Catalogue Number: L321
• Device Lot Number: 716330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 89 YR
• Patient Sex: Female