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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACCOLADE MRI DR; PACEMAKER
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BOSTON SCIENTIFIC CORPORATION ACCOLADE MRI DR; PACEMAKER Back to Search Results
Model Number L311
Device Problems Telemetry Discrepancy (1629); Interrogation Problem (4017)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/25/2022
Event Type  malfunction  
Event Description
It was reported that before implant, this pacemaker was interrogated several times with both a wand and radio frequency, with no successful results.Another programmer was used, nonetheless, it was unable to interrogate.The physician decided to use another pacemaker.The device will be return for analysis.No patient was involved.
 
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Brand Name
ACCOLADE MRI DR
Type of Device
PACEMAKER
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 Key15890051
MDR Text Key305522996
Report Number2124215-2022-50058
Device Sequence Number1
Product Code LWP
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P150012/S000
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 03/18/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberL311
Device Catalogue NumberL311
Device Lot Number634224
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/15/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/15/2022
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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