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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACCOLADE MRI EL DR; IMPLANTABLE DEVICE
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BOSTON SCIENTIFIC CORPORATION ACCOLADE MRI EL DR; IMPLANTABLE DEVICE Back to Search Results
Model Number L331
Device Problems Signal Artifact/Noise (1036); High impedance (1291); Over-Sensing (1438)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/30/2022
Event Type  malfunction  
Event Description
It was reported that this pacemaker system exhibited high, out-of-range (oor) right ventricular (rv) and right atrial (ra) pacing lead impedance (pli) measurements measuring greater than 3,000 ohms.A lead safety switch (lss) was declared which switched the pace/sense configuration from bipolar to unipolar.The device was re-programmed at the last in office as there were observations of high oor rv pli.Additionally, there is evidence of oversensing of noise on both leads, most likely due to prior programming to unipolar.Technical services recommended an x-ray and discussed possible causes.At this time, the system remains in service.No adverse patient effects were reported.
 
Event Description
It was reported that this pacemaker system exhibited high, out-of-range (oor) right ventricular (rv) and right atrial (ra) pacing lead impedance (pli) measurements measuring greater than 3,000 ohms.A lead safety switch (lss) was declared which switched the pace/sense configuration from bipolar to unipolar.The device was re-programmed at the last in office as there were observations of high oor rv pli.Additionally, there is evidence of oversensing of noise on both leads, most likely due to prior programming to unipolar.Technical services recommended an x-ray and discussed possible causes.At this time, the system remains in service.No adverse patient effects were reported.
 
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 product performance issue 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 (b)(6) 2020 to stabilize the electrical connection between the spring contact and the lead terminal.
 
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Brand Name
ACCOLADE MRI EL DR
Type of Device
IMPLANTABLE DEVICE
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 Key19035170
MDR Text Key339280324
Report Number2124215-2024-20239
Device Sequence Number1
Product Code LWP
UDI-Device Identifier00802526559266
UDI-Public00802526559266
Combination Product (y/n)N
Reporter Country CodeYM
PMA/PMN Number
P150012/S000
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/29/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date07/09/2023
Device Model NumberL331
Device Catalogue NumberL331
Device Lot Number943633
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/26/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/19/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age68 YR
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