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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACCOLADE MRI DR; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
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BOSTON SCIENTIFIC CORPORATION ACCOLADE MRI DR; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) Back to Search Results
Model Number L311
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problems No Patient Involvement (2645); Insufficient Information (4580)
Event Date 10/09/2020
Event Type  malfunction  
Event Description
It was reported that this dual chamber pacemaker during pre-implant preparation exhibited, a red screen displaying safety mode.The device was not used for the procedure and will be sent into boston scientific engineering for further analysis.No patient involvement.
 
Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Interrogation of the device confirmed it was operating in safety mode and that therapy remained available.Review of device memory identified an error.The error resulted in software resets performed in an attempt to correct an identified memory inconsistency.The corrupted memory was corrected in the laboratory and the device reverted to normal operation.The cause of the memory inconsistency was not able to be determined through laboratory testing but was likely the result of exposure to radiation, either therapeutic or environmental.
 
Event Description
It was reported that this dual chamber pacemaker during pre-implant preparation exhibited, a red screen displaying safety mode.The device was not used for the procedure and will be sent into boston scientific engineering for further analysis.No patient involvement.
 
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Brand Name
ACCOLADE 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
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 Key11182977
MDR Text Key227528821
Report Number2124215-2020-28248
Device Sequence Number1
Product Code LWP
UDI-Device Identifier00802526559228
UDI-Public00802526559228
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P150012/S000
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 02/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date08/06/2022
Device Model NumberL311
Device Catalogue NumberL311
Device Lot Number503996
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/13/2020
Date Manufacturer Received11/09/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/17/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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