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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 Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Inappropriate or Unexpected Reset (2959)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/14/2022
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that this pacemaker had entered safety mode.This pacemaker remains in service, however immediate device replacement and device return for analysis were recommended.No adverse patient effects were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.-- the product has been received for analysis.This report will be updated upon completion of analysis.
 
Event Description
It was reported that this pacemaker had entered safety mode.This pacemaker remains in service, however immediate device replacement and device return for analysis were recommended.No adverse patient effects were reported.Additional information received reported that this pacemaker was received for return analysis, which indicates this device was explanted.No additional adverse patient effects were reported.
 
Event Description
It was reported that this pacemaker had entered safety mode.This pacemaker remains in service, however immediate device replacement and device return for analysis were recommended.No adverse patient effects were reported.Additional information received reported that this pacemaker was received for return analysis, which indicates this device was explanted.No additional adverse patient effects were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.The product has been received for analysis.This report will be updated upon completion of 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.It was confirmed that critical therapy remained available.Review of device memory identified evidence that random access memory (ram) had been compromised, which can be indicative of power being lost and then restored.The device case was opened and the battery was removed and forwarded for detailed testing.Despite analysis, the root cause of the clinical observations could not be confirmed.
 
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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 Key16022417
MDR Text Key307915629
Report Number2124215-2022-54074
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 Health Professional
Reporter Occupation Physician
Remedial Action Replace
Type of Report Initial,Followup,Followup
Report Date 08/18/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date07/28/2018
Device Model NumberL311
Device Catalogue NumberL311
Device Lot Number243732
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/14/2022
Initial Date FDA Received12/21/2022
Supplement Dates Manufacturer Received12/21/2022
07/20/2023
Supplement Dates FDA Received12/23/2022
08/18/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/09/2016
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 Outcome(s) Hospitalization; Required Intervention;
Patient Age90 YR
Patient SexMale
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