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

Model Number L311

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

Patient Problems Unspecified Infection (1930); Sepsis (2067); Septic Shock (2068)

Event Date 07/28/2019

Event Type  Injury  

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

It was reported that this pacemaker was part of system revision due to infection with sepsis.Also, the patient developed septic shock.There were no additional adverse patient effects reported.The device was explanted.

Event Description

It was reported that this pacemaker was part of system revision due to infection with sepsis.Also, the patient developed septic shock.There were no additional adverse patient effects reported.The device was explanted.

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.This supplemental report is being filed to correct the device avail for evaluation, returned to manufacturer date, device eval by manufacturer, device eval by mfr sum attach, device not eval by mfr code, rfb device eval by mfr.

• Brand Name: ACCOLADE MRI DR
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 9285599
• MDR Text Key: 165274326
• Report Number: 2124215-2019-24402
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526559228
• UDI-Public: 00802526559228
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/01/2021
• Device Model Number: L311
• Device Catalogue Number: L311
• Device Lot Number: 418026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Date Manufacturer Received: 07/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 80