MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACUITY X4 SPIRAL S; IMPLANTABLE LEAD

Model Number 4675

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Data Problem (3196)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2023

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during the implant procedure for this left ventricular (lv) lead and cardiac resynchronization therapy defibrillator (crt-d) severe noise over sensing was observed when the lead was programmed at the vector that is used for lv lead measurements.As a consequence, no measurements could be completed.There were no problems observed with the other vectors.All possible resolutions such as replacing the red and black wires, replacing the pacing system analyzer cable, and checking for interference in the procedure area were performed, however, the event was not resolved.The physician requested a lead replacement; therefore, a new lv lead was used.After the new lead was implanted, the procedure and the measurements were all completed without any problems.It was requested that the corresponding lv lead be collected for analysis, however, due to insufficient confirmation of infection, it was discarded in accordance with the hospital rules.The initial crt-d remains in service at this time.No additional adverse patient effects were reported.

• 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 Key: 18450284
• MDR Text Key: 332266471
• Report Number: 2124215-2024-00373
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P010012/S398
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4675
• Device Catalogue Number: 4675
• Device Lot Number: 823056
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2023
• Initial Date FDA Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Female