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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACUITY X4 STRAIGHT; IMPLANTABLE LEAD
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BOSTON SCIENTIFIC CORPORATION ACUITY X4 STRAIGHT; IMPLANTABLE LEAD Back to Search Results
Model Number 4671
Device Problems High impedance (1291); Impedance Problem (2950); Positioning Problem (3009)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/20/2023
Event Type  malfunction  
Manufacturer Narrative
At this time, the product has not been returned.If the product is returned, analysis will be performed, and this report will be updated at that time.
 
Event Description
It was reported that this left ventricular (lv) lead was an attempted implant as impedance measurements were suboptimal during the procedure despite several repositioning attempts.As a result, the physician made the decision to remove the lead and implant a different one.The procedure was completed successfully, and no adverse patient effects were reported.The attempted lead is expected to be returned for analysis.
 
Event Description
It was reported that this left ventricular (lv) lead was an attempted implant as impedance measurements were suboptimal during the procedure despite several repositioning attempts.As a result, the physician made the decision to remove the lead and implant a different one.The procedure was completed successfully, and no adverse patient effects were reported.The attempted lead is expected to be returned for analysis.Additional information was received.The pacing impedance measurements were high out of range during the procedure.
 
Manufacturer Narrative
At this time, the product has not been returned.If the product is returned, analysis will be performed, and this report will be updated at that time.
 
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Brand Name
ACUITY X4 STRAIGHT
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 Key18471985
MDR Text Key332381506
Report Number2124215-2023-75589
Device Sequence Number1
Product Code LWP
Combination Product (y/n)Y
Reporter Country CodeSP
PMA/PMN Number
P010012/S398
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/11/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number4671
Device Catalogue Number4671
Device Lot Number869331
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/09/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/27/2023
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 SexMale
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