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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION; IMPLANTABLE PACEMAKER PULSE-GENERATOR
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BOSTON SCIENTIFIC CORPORATION; IMPLANTABLE PACEMAKER PULSE-GENERATOR Back to Search Results
Device Problems Pacing Problem (1439); Under-Sensing (1661)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/05/2023
Event Type  malfunction  
Event Description
It was reported that episode review was requested.Inappropriate therapy was delivered due to undersensing of an atrial event.A boston scientific technical services consultant documented the clinical observations and discussed programming options for this patient.Efforts were unsuccessful to obtain additional product and patient details.No adverse patient effects were reported.
 
Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
 
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Type of Device
IMPLANTABLE PACEMAKER PULSE-GENERATOR
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
Manufacturer Contact
timothy degroot
4100 hamline avenue north
saint paul, MN 55112
6515826168
MDR Report Key17027755
MDR Text Key316233947
Report Number2124215-2023-27362
Device Sequence Number1
Product Code DXY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 05/30/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/30/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Date Manufacturer Received05/05/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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