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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACUITY X4 SPIRAL S; IMPLANTABLE LEAD
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BOSTON SCIENTIFIC CORPORATION ACUITY X4 SPIRAL S; IMPLANTABLE LEAD Back to Search Results
Model Number 4674
Device Problems Failure to Capture (1081); Device Dislodged or Dislocated (2923)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/25/2024
Event Type  malfunction  
Event Description
It was reported that this left ventricular (lv) lead was unable to be implanted since experienced failure to capture due to a dislodgement that occurred.No additional information is available at the moment.No additional adverse patient effects were reported.
 
Event Description
It was reported that this left ventricular (lv) lead was unable to be implanted since experienced failure to capture due to a dislodgement that occurred.No additional information is available at the moment.No additional adverse patient effects were reported.
 
Manufacturer Narrative
Based on the instructions for use for this product, dislodgement behavior is a known inherent risk of the use of this lead.Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the lead was performed.Testing was completed to assess lead electrical performance and inner insulation integrity.Measurements throughout these tests were within normal limits.Microscopic inspections of the terminal pin assembly, lead body, and electrode tip found no anomalies.Laboratory testing was unable to reproduce the reported clinical observations and detailed analysis did not reveal any abnormalities.Laboratory analysis did not identify any lead characteristics that would have caused or contributed to the reported clinical observations.
 
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Brand Name
ACUITY X4 SPIRAL S
Type of Device
IMPLANTABLE LEAD
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
road 698, lot no. 12
dorado PR 00646 -260
*   00646-2602
Manufacturer Contact
timothy degroot
4100 hamline avenue north
saint paul, MN 55112
6515826168
MDR Report Key18707569
MDR Text Key336414691
Report Number2124215-2024-08829
Device Sequence Number1
Product Code LWP
UDI-Device Identifier00802526524554
UDI-Public00802526524554
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
P010012/S398
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/26/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/14/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number4674
Device Catalogue Number4674
Device Lot Number905714
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/01/2024
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/22/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/17/2023
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 Age75 YR
Patient SexMale
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