MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACUITY STEERABLE; IMPLANTABLE LEAD

Model Number 4554

Device Problems Signal Artifact/Noise (1036); High impedance (1291); High Capture Threshold (3266)

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

Event Date 03/24/2024

Event Type  malfunction  

Event Description

It was reported that the patient with the cardiac resynchronization therapy defibrillator (crt-d) device exhibited high out of range pacing impedance measurements, measuring at 2019 ohms on this left ventricular (lv) channel.The impedance measurements were later stable in the range of 400 ohms; however, the threshold value went up.Technical services (ts) reviewed and stated that there was little noise visible on the presenting electrogram (egm) but it was not oversensed.The noise was able to be reproduced in the clinic.This lv lead remains in service.No adverse patient effects were reported.

• Brand Name: ACUITY STEERABLE
• 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: 19058915
• MDR Text Key: 339815280
• Report Number: 2124215-2024-21088
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 00802526419324
• UDI-Public: 00802526419324
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P050046/S000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/08/2024

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: Lay User/Patient
• Device Expiration Date: 03/22/2008
• Device Model Number: 4554
• Device Catalogue Number: 4554
• Device Lot Number: 155162
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2006
• 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: 81 YR
• Patient Sex: Male