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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ESSENTIO MRI DR; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
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BOSTON SCIENTIFIC CORPORATION ESSENTIO MRI DR; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) Back to Search Results
Model Number L111
Device Problems Failure to Sense (1559); Use of Device Problem (1670); Defective Device (2588)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/21/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that this pacemaker was not successfully implanted due to unknown reason.This device was never in service.No adverse patient effects were reported.
 
Event Description
It was reported that during the implant procedure when the physician connected the right ventricular (rv) lead to the pacemaker there was no signal or sensing.The pacemaker was still outside of the pocket at this time.Initially the physician thought the rv port on the device was not functioning properly, so he requested a new device.A new device was successfully implanted.Upon further review it was found that during the case the stat button on the programmer was used, which automatically switched the sensing configuration to unipolar.This was determined to be the cause of the lack of signal and sensing during the attempted implant of this pacemaker.No adverse patient effects were reported.
 
Manufacturer Narrative
This report is being filed to correct the describe event or problem (b5) to provide better clarification then was on the initial report.Also corrected were the init rptr also sent rep to fda (e4) and device and patient codes (h6) that were inadvertently incorrection on the initial report.Patient code 3191 captures the prolonged procedure.
 
Manufacturer Narrative
The returned device was thoroughly inspected and analyzed.Visual inspection identified no anomalies.The device was able to be interrogated and a memory download was performed successfully.The device was then exposed to simulated heart load conditions, and the defibrillation and sensing functions were tested.The device operated appropriately, according to its performance specifications with no out of range measurements or interruptions in therapy output.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.
 
Event Description
It was reported that during the implant procedure when the physician connected the right ventricular (rv) lead to the pacemaker there was no signal or sensing.The pacemaker was still outside of the pocket at this time.Initially the physician thought the rv port on the device was not functioning properly, so he requested a new device.A new device was successfully implanted.Upon further review it was found that during the case the stat button on the programmer was used, which automatically switched the sensing configuration to unipolar.This was determined to be the cause of the lack of signal and sensing during the attempted implant of this pacemaker.No adverse patient effects were reported.
 
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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 Key10768083
MDR Text Key214109077
Report Number2124215-2020-22803
Device Sequence Number1
Product Code LWP
UDI-Device Identifier00802526558962
UDI-Public00802526558962
Combination Product (y/n)N
PMA/PMN Number
P150012/S000
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 02/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/27/2022
Device Model NumberL111
Device Catalogue NumberL111
Device Lot Number502001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/12/2021
Date Manufacturer Received01/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age77 YR
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