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

Model Number L331

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Presyncope (4410); Unspecified Heart Problem (4454)

Event Date 10/01/2022

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this patient with an implanted pacemaker system experienced palpitations, chest pains and near-syncope for nearly 30 minutes the night before.The patient reported a history of atrial tachycardia and atrial fibrillation, but the physician had no further information.Boston scientific technical services (ts) faxed the pacemaker device data reports to the physician.The reports included a stored atrial-tachy response (atr) episode from approximately three months earlier, and right atrial automatic threshold (raat) and right ventricular automatic threshold (rvat) test episodes from the day of the patient symptoms with appropriate lead threshold measurements of 0.4 volts and 1.3 volts, respectively.Ts noted that the presenting electrogram showed sinus tachycardia at 120 beats per minute (bpm).Ts explained that the atr rate cut off (rco) is programmed to 170 bpm and the vtachy rco is programmed to 160 bpm so the device would not store any rhythms below those rcos, but the device rate histograms did not show significant activity above 100 bpm.Attempts to gather additional information were unsuccessful.The device remains in-service.No additional adverse patient effects were reported.

• Brand Name: ACCOLADE 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: 15607724
• MDR Text Key: 301757695
• Report Number: 2124215-2022-41488
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526559266
• UDI-Public: 00802526559266
• 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: Physician
• Type of Report: Initial
• Report Date: 10/14/2022

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: 03/07/2024
• Device Model Number: L331
• Device Catalogue Number: L331
• Device Lot Number: 982512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2022
• Initial Date FDA Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 77 YR
• Patient Sex: Male