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

Model Number L331

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

Patient Problems Non specific EKG/ECG Changes (1817); Endocarditis (1834); Hypoxia (1918); Unspecified Infection (1930); Loss of consciousness (2418); Respiratory Failure (2484); Fluid Discharge (2686); Swelling/ Edema (4577)

Event Date 01/25/2021

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that this pacemaker was part of a system revision due to infection with fluid discharge and endocarditis.Reportedly, the patient presented to emergency room after being found unresponsive and has been treated for acute respiratory failure and hypoxia.The device remains in service.There were no additional adverse patient effects reported.

Manufacturer Narrative

Corrected b5 describe event or problem.Corrected h6 patient code description, patient code, impact code description, impact code.

Event Description

It was reported that during a device check, fluid was noted around the device and it appeared the patient may have developed an infection.Approximately one month later, the patient presented to the emergency room after being found unresponsive.It was reported that the patient received treatment for acute respiratory failure and hypoxia.The patient also had elevated troponin levels and endocarditis was noted.The patient subsequently expired approximately five days after presenting to the emergency room.There were no allegations against device functionality at that time.The local area field representative was contacted for additional information, however no further information was available.

• Brand Name: ACCOLADE MRI EL 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: 11735734
• MDR Text Key: 247669101
• Report Number: 2124215-2021-10309
• 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: 08/13/2021

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/17/2022
• Device Model Number: L331
• Device Catalogue Number: L331
• Device Lot Number: 909968
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/25/2021
• Initial Date FDA Received: 04/27/2021
• Supplement Dates Manufacturer Received: 07/26/2021
• Supplement Dates FDA Received: 08/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 74 YR