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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACCOLADE MRI SR; IMPLANTABLE DEVICE
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BOSTON SCIENTIFIC CORPORATION ACCOLADE MRI SR; IMPLANTABLE DEVICE Back to Search Results
Model Number L310
Device Problem Battery Problem (2885)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/09/2020
Event Type  malfunction  
Manufacturer Narrative
At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.
 
Event Description
It was reported during preparation for device implant, this device was at an end of life status during pre-implant interrogation.This device was not used and is expected to be returned for analysis.No patient involvement.
 
Manufacturer Narrative
At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.Device technical analysis: 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 brady therapy remained available.Review of device memory identified an error.The error resulted in software resets performed in an attempt to correct the identified memory inconsistency.The memory inconsistency 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.
 
Event Description
It was reported during preparation for device implant, this device was at an end of life status during pre-implant interrogation.This device was not used and is expected to be returned for analysis.No patient involvement.
 
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Brand Name
ACCOLADE MRI SR
Type of Device
IMPLANTABLE DEVICE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
MDR Report Key11182987
MDR Text Key227555087
Report Number2124215-2021-00175
Device Sequence Number1
Product Code LWP
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,foreig
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 Received01/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date10/01/2022
Device Model NumberL310
Device Catalogue NumberL310
Device Lot Number822648
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/21/2021
Date Manufacturer Received08/31/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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