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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACCOLADE MRI SR; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
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BOSTON SCIENTIFIC CORPORATION ACCOLADE MRI SR; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) Back to Search Results
Model Number L310
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/15/2022
Event Type  Injury  
Event Description
It was reported that this pacemaker was explanted on the same day that it was implanted.It was noted that the device was contaminated.Another pacemaker was successfully placed.No additional adverse patient effects were reported.
 
Manufacturer Narrative
The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.Dimensional analysis of the header was completed.Each port measured as expected.The device was then exposed to simulated heart load conditions, and the pacing and sensing functions were tested.Impedance testing was completed, and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.
 
Event Description
It was reported that this pacemaker was explanted on the same day that it was implanted.It was noted that the device was contaminated.Another pacemaker was successfully placed.No additional adverse patient effects were reported.
 
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Brand Name
ACCOLADE MRI SR
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 Key14800851
MDR Text Key294665814
Report Number2124215-2022-22714
Device Sequence Number1
Product Code LWP
UDI-Device Identifier00802526559204
UDI-Public00802526559204
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 Physician
Type of Report Initial,Followup
Report Date 04/07/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberL310
Device Catalogue NumberL310
Device Lot Number861902
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/07/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/14/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age68 YR
Patient SexMale
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