MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACUITY STEERABLE; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number	4554
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that this left ventricular (lv) lead exhibited high out-of-range pace impedance measurements greater than 2,000 ohms, and a lv lead safety switch (lss) was triggered due to a high out-of-range lv pace impedance measurement of 2,016 ohms.Lv impedance measurements have been fairly stable since a recent device changeout in may, with a gradual increase in impedance measurements.Technical services (ts) discussed troubleshooting options and programming considerations.It was recommended to bring the patient into the clinic for lv lead evaluation to rule-out possible lead integrity concerns, assess lv lead vectors, and consider raising the impedance alert value.This lv lead remains in service.No adverse patient effects were reported.

• Brand Name: ACUITY STEERABLE
• Common Device Name: PERMANENT DEFIBRILLATOR ELECTRODES
• 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: 20026049
• Report Number: 2124215-2024-51498
• Device Sequence Number: 21019831
• Product Code: NVY
• UDI-Device Identifier: 00802526419324
• UDI-Public: 00802526419324
• Combination Product (Y/N): Y
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P050046/S000
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/19/2024

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: 04/24/2010
• Device Model Number: 4554
• Device Catalogue Number: 4554
• Device Lot Number: 166243
• 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: 08/05/2024
• Initial Report FDA Received Date: 08/22/2024
• Date Device Manufactured: 04/24/2008
• 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: 76 YR
• Patient Sex: Female