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

Model Number L101

Device Problems Signal Artifact/Noise (1036); Failure to Capture (1081); Over-Sensing (1438); Pacing Problem (1439); Low impedance (2285)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2019

Event Type  Injury  

Event Description

It was reported that the patient with this pacemaker system presented to the emergency room (er) with pauses in pacing delivery.Technical services (ts) analyzed device data and found two stored signal artifact monitoring (sam) events with a minute ventilation (mv) vector switch.It was observed that there were right ventricular (rv) lead impedances less than 200 ohms as well as noise which resulted in oversensing and multiple stored events.This lead was set to unipolar configuration because, on bipolar, there was no capture.There was no pacing inhibition found on the stored events.It was noted that the physician had reprogrammed this pacemaker.Ts provided additional troubleshooting to field sales personnel who discussed with physician.The patient was admitted to the hospital and a temporary pacing wire was implanted.The rv lead is a non-boston scientific product.No additional adverse patient effects were reported.Currently, this pacemaker system remains in service.

Event Description

It was reported that the patient with this pacemaker system presented to the emergency room (er) with pauses in pacing delivery.Technical services (ts) analyzed device data and found two stored signal artifact monitoring (sam) events with a minute ventilation (mv) vector switch.It was observed that there were right ventricular (rv) lead impedances less than 200 ohms as well as noise which resulted in oversensing and multiple stored events.This lead was set to unipolar configuration because, on bipolar, there was no capture.There was no pacing inhibition found on the stored events.It was noted that the physician had reprogrammed this pacemaker.Ts provided additional troubleshooting to field sales personnel who discussed with physician.The patient was admitted to the hospital and a temporary pacing wire was implanted.The rv lead is a non-boston scientific product.No additional adverse patient effects were reported.Currently, this pacemaker system remains in service.According to additional information received, this pacemaker was explanted and replaced with a non-boston scientific device.No additional adverse patient effects were reported.This product has been received by boston scientific and an investigation is expected to be performed.

Event Description

It was reported that the patient with this pacemaker system presented to the emergency room (er) with pauses in pacing delivery.Technical services (ts) analyzed device data and found two stored signal artifact monitoring (sam) events with a minute ventilation (mv) vector switch.It was observed that there were right ventricular (rv) lead impedances less than 200 ohms as well as noise which resulted in oversensing and multiple stored events.This lead was set to unipolar configuration because, on bipolar, there was no capture.There was no pacing inhibition found on the stored events.It was noted that the physician had reprogrammed this pacemaker.Ts provided additional troubleshooting to field sales personnel who discussed with physician.The patient was admitted to the hospital and a temporary pacing wire was implanted.The rv lead is a non-boston scientific product.No additional adverse patient effects were reported.Currently, this pacemaker system remains in service.According to additional information received, this pacemaker was explanted and replaced with a non-boston scientific device.No additional adverse patient effects were reported.This product has been received by boston scientific and an investigation is expected to be performed.

Manufacturer Narrative

The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.Dimensional analysis of the header was completed.Each port measured as expected.The device was then exposed to simulated heart load conditions, and the pacing, and sensing functions were tested.Impedance testing was completed, and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.

• Brand Name: ESSENTIO 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: 15906022
• MDR Text Key: 304711173
• Report Number: 2124215-2022-50501
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526558924
• UDI-Public: 00802526558924
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N970003/S167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/17/2020
• Device Model Number: L101
• Device Catalogue Number: L101
• Device Lot Number: 775035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2018
• 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): Required Intervention; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Male