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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ESSENTIO EL DR; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
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BOSTON SCIENTIFIC CORPORATION ESSENTIO EL DR; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) Back to Search Results
Model Number L121
Device Problems Failure to Capture (1081); Pacing Problem (1439); High Capture Threshold (3266)
Patient Problems Syncope (1610); Bruise/Contusion (1754); Syncope/Fainting (4411)
Event Date 08/29/2019
Event Type  Injury  
Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
 
Event Description
It was reported that this patient is pacemaker dependent and has experienced recent episodes of loss of consciousness.Minute ventilation (mv) had previously been programmed off due to advisory recommendations.The caller stated device evaluation was normal with stable thresholds and no noise.The episodes were thought to be possibly related to intermittent loss of capture.A boston scientific technical services consultant documented the reported clinical observations and discussed further troubleshooting with the caller.No additional adverse patient effects were reported.
 
Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
 
Event Description
It was reported that this patient is pacemaker dependent and has experienced recent episodes of loss of consciousness.Minute ventilation (mv) had previously been programmed off due to advisory recommendations.The caller stated device evaluation was normal with stable thresholds and no noise.The episodes were thought to be possibly related to intermittent loss of capture.A boston scientific technical services consultant documented the reported clinical observations and discussed further troubleshooting with the caller.No additional adverse patient effects were reported.It was reported that this patient had experienced several syncopal events that resulted in head bruises.There is no known cause for the events and the patient is going to undergo a neurological workup.No additional adverse patient effects were reported.
 
Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
 
Event Description
It was reported that this patient is pacemaker dependent and has experienced recent episodes of loss of consciousness.Minute ventilation (mv) had previously been programmed off due to advisory recommendations.The caller stated device evaluation was normal with stable thresholds and no noise.The episodes were thought to be possibly related to intermittent loss of capture.A boston scientific technical services consultant documented the reported clinical observations and discussed further troubleshooting with the caller.No additional adverse patient effects were reported.It was reported that this patient had experienced several syncopal events that resulted in head bruises.There is no known cause for the events and the patient is going to undergo a neurological workup.No additional adverse patient effects were reported.It was reported that this device was subsequently explanted and replaced with a competitive device.No additional adverse patient effects were reported.
 
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Brand Name
ESSENTIO 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 Key9274283
MDR Text Key164913427
Report Number2124215-2019-23722
Device Sequence Number1
Product Code LWP
UDI-Device Identifier00802526558986
UDI-Public00802526558986
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N970003/S167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 04/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date09/09/2017
Device Model NumberL121
Device Catalogue NumberL121
Device Lot Number704924
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/15/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/09/2015
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention; Hospitalization; Other;
Patient Age69 YR
Patient SexFemale
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