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

Model Number	4555
Medical Device Problem Codes	Failure to Capture (1081); Over-Sensing (1438)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this left ventricular (lv) lead exhibited oversensing and possible intermittent loss of capture.Technical services (ts) recommended the patient be brought into the clinic to confirm lv capture as well as programming changes.No adverse patient effects were reported.This lv lead remains in service.

• Brand Name: ACUITY STEERABLE
• Common Device Name: 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: 20506723
• Report Number: 2124215-2024-66116
• Device Sequence Number: 12872958
• Product Code: NVY
• UDI-Device Identifier: 00802526419447
• UDI-Public: 00802526419447
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P050046/S000
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/22/2024

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/29/2011
• Device Model Number: 4555
• Device Catalogue Number: 4555
• Device Lot Number: 183260
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 10/22/2024
• Date Device Manufactured: 08/29/2009
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Male