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

Model Number	4555
Medical Device Problem Codes	Signal Artifact/Noise (1036); Failure to Capture (1081); Fracture (1260); High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cardiac resynchronization therapy defibrillator (crt-d) exhibited loss of capture in all of the pacing vectors for the left ventricular (lv) lead.Noise was also seen in all sensing vectors except for tip to ring, and system impedance has increased from 400 ohms to 1600-2000 ohms.Technical services (ts) was contacted, and ts discussed evaluating the lv lead.X-ray imaging was performed, showing a clear fracture of the lv lead conductors.The lv lead remains in service as the physician makes a decision on intervention.No adverse patient effects were reported.

• 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: 20467214
• Report Number: 2124215-2024-64832
• Device Sequence Number: 7254982
• Product Code: NVY
• UDI-Device Identifier: 00802526419447
• UDI-Public: 00802526419447
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P050046/S000
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/16/2024

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: 02/17/2012
• Device Model Number: 4555
• Device Catalogue Number: 4555
• Device Lot Number: 187688
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 10/16/2024
• Date Device Manufactured: 02/17/2010
• 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: 75 YR
• Patient Sex: Male