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

Model Number L331

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

Patient Problems Wound Dehiscence (1154); Erosion (1750); Edema (1820); Unspecified Infection (1930); Skin Irritation (2076); Swelling (2091); No Code Available (3191); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)

Event Date 10/12/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).This product is not expected to be returned.If the product is returned, analysis would be performed and this report would be updated at that time.

Event Description

It was reported that the patient was admitted to hospital as this implantable pulse generator (pacemaker) was infected.Swelling, irritation and an edema were observed in the skin.The swelled skin eventually peeled off resulting in an erosion and exposing the device.Eventually, this device along with the leads were explanted, there is no information regarding when is a new system going to be implanted.It is not expected that this device returns for analysis.No additional adverse patient effects were reported.

Manufacturer Narrative

Corrected field: -b5 (product problem): the text was corrected as a leadless pacemaker was implanted the following week of the explant procedure.This product is not expected to be returned.If the product is returned, analysis would be performed and this report would be updated at that time.

Event Description

It was reported that the patient was admitted to hospital as this implantable pulse generator (pacemaker) was infected.Swelling, irritation and an edema were observed in the skin.The swelled skin eventually peeled off resulting in an erosion and exposing the device.Eventually, this device along with the leads were explanted, a leadless pacemaker was implanted the following week of this explant procedure.It is not expected that this device returns for analysis.No additional adverse patient effects were reported.

• Brand Name: ACCOLADE MRI EL DR
• Type of Device: IMPLANTABLE PULSE GENERATOR (PACEMAKER)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 11182579
• MDR Text Key: 227501360
• Report Number: 2124215-2021-00516
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526559266
• UDI-Public: 00802526559266
• 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: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/09/2020
• Device Model Number: L331
• Device Catalogue Number: L331
• Device Lot Number: 780413
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/22/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 89 YR