MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACCOLADE MRI SR; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number L310

Device Problem Defective Device (2588)

Patient Problem Cardiopulmonary Arrest (1765)

Event Date 10/22/2019

Event Type  Death  

Event Description

It was reported that a code was called during the implant procedure of this pacemaker.It was noted that this was unrelated to the device.The patient remained on a ventilator the following day and expired five days later.

• Brand Name: ACCOLADE MRI SR
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• 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: 9650690
• MDR Text Key: 177116668
• Report Number: 2124215-2020-02200
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526559204
• UDI-Public: 00802526559204
• Combination Product (y/n): N
• 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: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/20/2021
• Device Model Number: L310
• Device Catalogue Number: L310
• Device Lot Number: 782968
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2019
• 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): Death
• Patient Age: 81 YR