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

Model Number L331

Device Problems Pacing Problem (1439); Battery Problem (2885)

Patient Problems Atrial Flutter (1730); Chest Pain (1776); Dysphagia/ Odynophagia (1815); Dyspnea (1816); Device Overstimulation of Tissue (1991); Dizziness (2194); Anxiety (2328); Discomfort (2330); Presyncope (4410); Heart Block (4444); Unspecified Heart Problem (4454); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/27/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was that the patient with this pacemaker experienced increased heart rate at 100s beats per minute (bpm) all the time.In addition, this patient went to the emergency room (er) and consult transmission showed increased heart rate and sent home as it was not life threatening.Patient was being seen again in the hospital experienced fluttering in the chest and told by the physician that the atrial was going too fast and ventricular needed to be paced.Boston scientific technical services (ts) discussed basic function of a single chamber device versus a dual chamber device and referred to the implanting physician.Additional information received indicated that this patient experienced constant pain and discomfort.The health care professional felt the threshold test when started at 7.5 volts.Patient did have a complete heart block and so was paced all the time with 2.8 volts@0.4 milliseconds in the right ventricle (rv) and 100% paced.Moreover, device power consumption was noted to be a bit high.Device data analysis was requested and showed that this device was unclear if it operated normally.The power consumption appears normal for the most part but has periods of high usage.Suspected cause may be due to radio frequency use.Furthermore, ts recommended to do another remote transmission to check power consumption.As of this time, this device remains in service.No adverse patient effects were reported.

Manufacturer Narrative

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

Event Description

It was that the patient with this pacemaker experienced increased heart rate at 100s beats per minute (bpm) all the time.In addition, this patient went to the emergency room (er) and consult transmission showed increased heart rate and sent home as it was not life threatening.Patient was being seen again in the hospital experienced fluttering in the chest and told by the physician that the atrial was going too fast and ventricular needed to be paced.Boston scientific technical services (ts) discussed basic function of a single chamber device versus a dual chamber device and referred to the implanting physician.Additional information received indicated that this patient experienced constant pain and discomfort.The health care professional felt the threshold test when started at 7.5 volts.Patient did have a complete heart block and so was paced all the time with 2.8 volts@0.4 milliseconds in the right ventricle (rv) and 100% paced.Moreover, device power consumption was noted to be a bit high.Device data analysis was requested and showed that this device was unclear if it operated normally.The power consumption appears normal for the most part but has periods of high usage.Suspected cause may be due to radio frequency use.Furthermore, ts recommended to do another remote transmission to check power consumption.As of this time, this device remains in service.No adverse patient effects were reported.It was reported that this patient experienced increased heart rate post implant of this pacemaker.This patient presented to the emergency room (er) in which a transmission confirmed increased heart rate.This patient was sent home at that time as it was not life threatening.Patient was being seen again in the hospital experiencing fluttering in the chest and was told by the physician that the atrium was working too fast, and the ventricle needed to be paced.It was noted that this patient experienced constant pain and discomfort and could feel the threshold testing while it occurred.This patient has complete heart block and was pacemaker dependent.It was suspected that this icd was exhibiting high power consumption.A request was made for disk analysis which noted it was unclear if this was normal operation.The power consumption appeared normal with periods of high usage and was suspected to be due to radio frequency.Ts recommended an additional remote transmission to verify power consumption however, that the power consumption does not explain this patients symptoms.Technical services (ts) discussed basic function of a single chamber device versus a dual chamber device and referred this patient to their implanting physician.Then, the patient noted they experienced a near syncopal episode after using a garmin watch and starkey hearing aids.The patient reported that cardiopulmonary resuscitation (cpr) was performed on them however, no details are known at this time.This patient has called in several times with a list of symptoms including chest pain, fluttering, shortness of breath, dizziness, difficulty swallowing, tightness in left shoulder, palpitations.Noted that they have suffered traumatic brain injury and has an extremely high level of anxiety.This patient mentioned they knew where the leads were located and that they would remove them themselves.This patient alleges that this pacemaker has caused all their health issues and is not right for them.As of this time, this icd remains in service.No adverse patient effects were reported.

• 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
• 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: 15910288
• MDR Text Key: 305876503
• Report Number: 2124215-2022-50553
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526559266
• UDI-Public: 00802526559266
• 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,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/13/2022

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 Model Number: L331
• Device Catalogue Number: L331
• Device Lot Number: 548555
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/10/2022
• Initial Date FDA Received: 12/02/2022
• Supplement Dates Manufacturer Received: 12/07/2022
• Supplement Dates FDA Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2022
• 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
• Patient Age: 57 YR
• Patient Sex: Female