MAUDE Adverse Event Report: BOSTON SCIENTFIC INGENIO; IMPLANTABLE DEVICE

Model Number	K172
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.The device was then exposed to simulated heart load conditions, and the pacing, and sensing functions were tested.Memory review confirmed that the device underwent a reset due to memory corruption which resulted in the observed error message.Following the reset, the device reverted to a safety mode with limited programmability, in which single chamber pacing were available.
Event or Problem Description
It was reported that this product was returned with no reported product performance issues or adverse patient effects.Analysis completed in our post market quality assurance laboratory determined that the device exhibited premature battery depletion identified by a product performance issue.No adverse patient effects were reported.

• Brand Name: INGENIO
• Common Device Name: IMPLANTABLE DEVICE
• Manufacturer (Section D): BOSTON SCIENTFIC
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: tmothy degroot
• MDR Report Key: 19353983
• Report Number: 2124215-2024-30624
• Device Sequence Number: 12629114
• Product Code: LWP
• UDI-Device Identifier: 00802526516818
• UDI-Public: 00802526516818
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: N970003/S132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/20/2024

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: 01/20/2017
• Device Model Number: K172
• Device Catalogue Number: K172
• Device Lot Number: 489080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female