Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACUITY X4 SPIRAL S; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION ACUITY X4 SPIRAL S; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) Back to Search Results
Model Number 4674
Device Problems Difficult to Remove (1528); Positioning Problem (3009); High Capture Threshold (3266)
Patient Problem Vascular Dissection (3160)
Event Date 04/25/2023
Event Type  malfunction  
Event Description
It was reported that left ventricular (lv) lead was not successfully implanted due to placement difficulty and difficult to retract.The physician had difficulty pulling back the lead into the coronary sinus past a primary bifurcation.The physician did several excessive manipulations of the catheter to return the lead back to the coronary sinus.After the lead was removed the scrub tech noticed excessive tissue on the fins of the lead.Additional contrast was when injected to look for new potential lead placements and it was noted that a potential dissection had taken place.The lead was never in service.No adverse patient effects were reported.Additional information received from the field indicated that it was not known if the lead was the exact cause of dissection.However, there was no additional intervention done for the dissection.Furthermore, a high capture of thresholds was observed resulting in the removal of the lead.
 
Manufacturer Narrative
The product has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental report will be filed.
 
Manufacturer Narrative
The product has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental report will be filed.Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the lead was performed.Detailed analysis did not confirm high-capture-threshold based on normal lead resistance measurements, a passing hipot test and inspection which showed no conductor issues.However, difficult to position and difficult-to-remove allegation was confirmed due to tissue noted on the lead near the tip as was mentioned in the complaint.Furthermore, known inherent risk conclusion was based on the direct observation of tissue entwined near the tip.Susceptibility of lead tips (both active and passive) to snagging tissue is a known risk.
 
Event Description
It was reported that left ventricular (lv) lead was not successfully implanted due to placement difficulty and difficult to retract.The physician had difficulty pulling back the lead into the coronary sinus past a primary bifurcation.The physician did several excessive manipulations of the catheter to return the lead back to the coronary sinus.After the lead was removed the scrub tech noticed excessive tissue on the fins of the lead.Additional contrast was when injected to look for new potential lead placements and it was noted that a potential dissection had taken place.The lead was never in service.No adverse patient effects were reported.Additional information received from the field indicated that it was not known if the lead was the exact cause of dissection.However, there was no additional intervention done for the dissection.Furthermore, a high capture of thresholds was observed resulting in the removal of the lead.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ACUITY X4 SPIRAL S
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
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 Key16969647
MDR Text Key315836280
Report Number2124215-2023-25233
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,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/15/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/19/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number4674
Device Catalogue Number4674
Device Lot Number894244
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/01/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/25/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/23/2023
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 Age68 YR
Patient SexFemale
-
-