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

Model Number L111

Device Problems High impedance (1291); Over-Sensing (1438); Pacing Problem (1439)

Patient Problems Syncope (1610); No Code Available (3191); Syncope/Fainting (4411)

Event Date 04/27/2020

Event Type  Injury  

Event Description

It was reported that the patient with this pacemaker presented to the clinic following a syncopal episode that occurred while she was in the shower.A copy of device data was preserved and submitted for analysis.Technical services (ts) review of device data found that both the right atrial and right ventricular leads were in a unipolar configuration following a lead safety switch for high, out-of-range impedances.A signal artifact monitoring episode had detected noise from the minute ventilation feature.Noise was still present on both the right atrial and ventricular leads; inappropriate episodes of sudden brady response and non-sustained ventricular tachycardia were recorded.Pacing inhibition of greater than two seconds was noted.A chest x-ray was performed which indicated subclavian crush on at least one of the leads, likely the ra.Ts suggested considering a lead revision.The leads were surgically abandoned and the device was explanted but has not been returned for analysis.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited intermittent impedance measurements with no conclusive evidence of a malfunction or inadequate lead-to-device connection; please refer to the description for more information regarding the specific circumstances of this event.Investigation has determined that this type of event is likely the result of an intermittent high impedance condition associated with the device spring contact and lead terminal ring.A design enhancement was implemented in 2020 to stabilize the electrical connection between the spring contact and the lead terminal.Also, investigation of the available information determined this device exhibited oversensing of noise generated by the minute ventilation (mv)/respiratory sensor that is related to a high impedance condition.Please see the description for more information regarding the specific circumstances of this event.This device was included in the recent minute ventilation sensor signal oversensing advisory population.(b)(4).

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited intermittent impedance measurements with no conclusive evidence of a malfunction or inadequate lead-to-device connection; please refer to the description for more information regarding the specific circumstances of this event.Investigation has determined that this type of event is likely the result of an intermittent high impedance condition associated with the device spring contact and lead terminal ring.A design enhancement was implemented in 2020 to stabilize the electrical connection between the spring contact and the lead terminal.Also, investigation of the available information determined this device exhibited oversensing of noise generated by the minute ventilation (mv)/respiratory sensor that is related to a high impedance condition.Please see the description for more information regarding the specific circumstances of this event.This device was included in the recent minute ventilation sensor signal oversensing advisory population.Code 3191 was used to capture surgical intervention.Further engineering investigation was conducted of the device diagnostic data that was downloaded and submitted to boston scientific technical services for review.It was determined that the out of range impedance measurements were not associated with the device spring contact and lead terminal ring as previously reported.As all available evidence indicates the cause of the out of range impedance measurements were due to the leads and not the device.

Event Description

It was reported that the patient with this pacemaker presented to the clinic following a syncopal episode that occurred while she was in the shower.A copy of device data was preserved and submitted for analysis.Technical services (ts) review of device data found that both the right atrial and right ventricular leads were in a unipolar configuration following a lead safety switch for high, out-of-range impedances.A signal artifact monitoring episode had detected noise from the minute ventilation feature.Noise was still present on both the right atrial and ventricular leads; inappropriate episodes of sudden brady response and non-sustained ventricular tachycardia were recorded.Pacing inhibition of greater than two seconds was noted.A chest x-ray was performed which indicated subclavian crush on at least one of the leads, likely the ra.Ts suggested considering a lead revision.The leads were surgically abandoned and the device was explanted but has not been returned for analysis.This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited intermittent impedance measurements with no conclusive evidence of a malfunction or inadequate lead-to-device connection; please refer to the description for more information regarding the specific circumstances of this event.Investigation has determined that this type of event is likely the result of an intermittent high impedance condition associated with the device spring contact and lead terminal ring.A design enhancement was implemented in 2020 to stabilize the electrical connection between the spring contact and the lead terminal.Also, investigation of the available information determined this device exhibited oversensing of noise generated by the minute ventilation (mv)/respiratory sensor that is related to a high impedance condition.Please see the description for more information regarding the specific circumstances of this event.This device was included in the recent minute ventilation sensor signal oversensing advisory population.Code 3191 was used to capture surgical intervention.

• Brand Name: ESSENTIO 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
• MDR Report Key: 11227817
• MDR Text Key: 241236505
• Report Number: 2124215-2020-28964
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526558962
• UDI-Public: 00802526558962
• 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
• Type of Report: Initial,Followup
• Report Date: 10/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/15/2019
• Device Model Number: L111
• Device Catalogue Number: L111
• Device Lot Number: 311086
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 59 YR