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

Model Number L311

Device Problems Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Undesired Nerve Stimulation (1980); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/04/2022

Event Type  Injury  

Event Description

It was reported that the patient with this pacemaker felt getting shock from this device.Boston scientific technical services (ts) discussed that the device does not have the capability to provide shock and referred the patient to the physician.Furthermore, the patient reported back indicating having a surgery to move the device up towards the clavicle due to the apparent reported patient symptom.The device remains in service.No additional adverse patient effects were reported.

Manufacturer Narrative

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

Event Description

It was reported that the patient with this pacemaker felt getting shock from this device.Boston scientific technical services (ts) discussed that the device does not have the capability to provide shock and referred the patient to the physician.Furthermore, the patient reported back indicating having a surgery to move the device up towards the clavicle due to the apparent reported patient symptom.The device remains in service.No additional adverse patient effects were reported.Additional information from the field indicated that the patient symptom was not device-related.However, a pocket revision was performed to move the device up towards the clavicle due to the apparent reported patient symptom.The device remains in service.No additional adverse patient effects were reported.

Manufacturer Narrative

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

• 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
• 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: 15377016
• MDR Text Key: 299450486
• Report Number: 2124215-2022-34890
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526559228
• UDI-Public: 00802526559228
• 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: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/12/2022

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/12/2024
• Device Model Number: L311
• Device Catalogue Number: L311
• Device Lot Number: 621271
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/18/2022
• Initial Date FDA Received: 09/08/2022
• Supplement Dates Manufacturer Received: 09/08/2022
• Supplement Dates FDA Received: 09/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2022
• 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): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female