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

Model Number 4555

Device Problems Signal Artifact/Noise (1036); Failure to Capture (1081); High impedance (1291)

Patient Problem Fatigue (1849)

Event Date 11/16/2022

Event Type  Injury  

Event Description

It was reported that this left ventricular (lv) lead exhibited and increase in impedance measurements.Also, noisy signals were observed.No loss of capture (loc) or high capture thresholds were noted.This patient stated feeling fatigued.Further information was received that this lead was surgically abandoned due to a product performance issue.No additional adverse patient effects were reported.

Event Description

It was reported that this left ventricular (lv) lead exhibited and increase in impedance measurements.Also, noisy signals were observed.No loss of capture (loc) or high capture thresholds were noted.This patient stated feeling fatigued.Further information was received that this lead was surgically abandoned due to loss of capture (loc).No additional 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: 18916567
• MDR Text Key: 337811708
• Report Number: 2124215-2024-15939
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 00802526419447
• UDI-Public: 00802526419447
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/23/2011
• Device Model Number: 4555
• Device Catalogue Number: 4555
• Device Lot Number: 182039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2009
• 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 Outcome(s): Required Intervention; Hospitalization
• Patient Age: 57 YR
• Patient Sex: Female