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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 4675
Device Problems Failure to Capture (1081); Fracture (1260); Device Dislodged or Dislocated (2923); High Capture Threshold (3266)
Patient Problem Vascular Dissection (3160)
Event Date 04/12/2021
Event Type  Injury  
Event Description
It was reported that this left ventricular (lv) lead was explanted due to dislodgment, high capture thresholds, loss of capture, conductor fracture, and dissection.Multiple vectors were tested in attempts to obtain capture, however only one vector detected capture, and had high capture threshold.The lead was attempted to be repositioned, however loss of capture continued.A new lv lead was successfully placed.No additional adverse patient effects were reported.
 
Event Description
It was reported that this left ventricular (lv) lead was explanted due to dislodgment, high capture thresholds, loss of capture, conductor fracture, and dissection.Multiple vectors were tested in attempts to obtain capture, however only one vector detected capture, and had high capture threshold.The lead was attempted to be repositioned, however loss of capture continued.A new lv lead was successfully placed.No additional adverse patient effects were reported.
 
Manufacturer Narrative
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/outer insulation integrity.Measurements throughout these tests were within normal limits.Induced electro-cautery damage was noted on the insulation due to the explant procedure.Microscopic inspections of the terminal pin assembly, lead body, and electrode tip found no additional 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
MDR Report Key12270925
MDR Text Key264927051
Report Number2124215-2021-22955
Device Sequence Number1
Product Code LWP
Combination Product (y/n)Y
PMA/PMN Number
P010012/S398
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 10/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date07/10/2022
Device Model Number4675
Device Catalogue Number4675
Device Lot Number812006
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/11/2021
Date Manufacturer Received08/06/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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