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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Implant Pain (4561)
Event Date 08/19/2022
Event Type  Injury  
Event Description
It was reported that the patient with this pacemaker had painful pocket hematoma from the recent device implant.The physician performed a pocket evacuation to remove the hematoma.The device was repositioned to sub pectoral and placed pressure dressing on the wound.The device remains in service.No additional adverse patient effects were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient with this pacemaker had painful pocket hematoma from the recent device implant.The physician performed a pocket evacuation to remove the hematoma.The device was repositioned to sub pectoral and placed pressure dressing on the wound.The device remains in service.No additional adverse patient effects were reported.Additional information was received indicating that this device was surgically explanted.No additional adverse patient effects reported.This event was previously reported.See mfr.Report # 2124215-2023-54325.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.This supplemental report was created to update the entry in d6b: explant date and h6: impact codes.This event was previously reported.See mfr.Report # 2124215-2023-54325.
 
Event Description
It was reported that the patient with this pacemaker had painful pocket hematoma from the recent device implant.The physician performed a pocket evacuation to remove the hematoma.The device was repositioned to sub pectoral and placed pressure dressing on the wound.The device remains in service.No additional adverse patient effects were reported.Additional information was received indicating that this device was surgically explanted.No additional adverse patient effects reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.This supplemental report was created to update the entry in d6b: explant date and h6: impact codes.This event was previously reported.See mfr.Report # 2124215-2023-54325.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.
 
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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 degroot
4100 hamline avenue north
saint paul, MN 55112
6515826168
MDR Report Key15401605
MDR Text Key299675222
Report Number2124215-2022-35313
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,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 02/02/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/12/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date10/27/2023
Device Model NumberL311
Device Catalogue NumberL311
Device Lot Number586081
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/30/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/04/2021
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) Required Intervention; Hospitalization;
Patient Age59 YR
Patient SexMale
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