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

Model Number L310

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

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930)

Event Date 03/15/2022

Event Type  Injury  

Event Description

It was reported that the patient with this pacemaker patient had excess bleeding in pocket leading to infection.A revision was performed and the pacemaker along with the right ventricular (rv) lead were explanted.The patient was treated with intravenous antibiotics.There were no additional adverse patient effects reported.

Manufacturer Narrative

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

• 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: 14229414
• MDR Text Key: 290262165
• Report Number: 2124215-2022-13637
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526559204
• UDI-Public: 00802526559204
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/28/2022
• Device Model Number: L310
• Device Catalogue Number: L310
• Device Lot Number: 818353
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2020
• 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): Required Intervention; Hospitalization
• Patient Age: 86 YR
• Patient Sex: Male