MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VISIONIST CRT-P; CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P)

Model Number	U226
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a clinic visit, this cardiac resynchronization therapy pacemaker (crt-p) was found to be in safety mode.Subsequently, a device replacement procedure was performed, the crt-p was explanted and replaced with a new device.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that during a clinic visit, this cardiac resynchronization therapy pacemaker (crt-p) was found to be in safety mode.Subsequently, a device replacement procedure was performed, the crt-p was explanted and replaced with a new device.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Analysis of the device confirmed it was operating in safety mode and that critical therapy remained available.Engineers determined that this device was demonstrating behavior consistent with a high impedance within the battery.The high battery impedance put this device at risk of experiencing transient voltage decreases (and associated resets) during telemetry or other normal, higher-power operations.When battery voltage drops below a minimum threshold, a system reset is performed.If three system resets occur within a 48-hour period, the device is designed to enter safety mode operation to maintain back-up pacing with pre-defined settings.Boston scientific has issued a field safety notice to notify physicians of the potential for accolade pacemaker and cardiac resynchronization therapy pacemaker (crt-p) devices to exhibit this behavior.

• Brand Name: VISIONIST CRT-P
• Common Device Name: CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 20364347
• Report Number: 2124215-2024-62085
• Device Sequence Number: 6783335
• Product Code: NKE
• UDI-Device Identifier: 00802526559457
• UDI-Public: 00802526559457
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P030005/S138
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/13/2019
• Device Model Number: U226
• Device Catalogue Number: U226
• Device Lot Number: 700511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2024
• Supplement Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2017
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male