MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INGENIO; IMPLANTABLE DEVICE

Model Number	K172
Medical Device Problem Code	Low impedance (2285)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this pacemaker and right ventricular (rv) lead had an alert last month for low out of range pacing impedances less than 200 ohms in bipolar configuration.The lead was tested in unipolar where the impedances were around 400 ohms, and 500 ohms in bipolar.Isometrics did not reproduce noise in unipolar or bipolar, so the lead was programmed back to bipolar.The patient was in the hospital for syncope due to low blood sugar.The system remains in-service at this time.No adverse patient effects were reported.
Event or Problem Description
It was reported that this pacemaker and right ventricular (rv) lead had an alert last month for low out of range pacing impedances less than 200 ohms in bipolar configuration.The lead was tested in unipolar where the impedances were around 400 ohms, and 500 ohms in bipolar.Isometrics did not reproduce noise in unipolar or bipolar, so the lead was programmed back to bipolar.The patient was in the hospital for syncope due to low blood sugar.The system remains in-service at this time.No adverse patient effects were reported.This pacemaker device was subsequently explanted and returned to boston scientific.
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.Impedance testing was completed, and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.

• Brand Name: INGENIO
• Common Device Name: IMPLANTABLE DEVICE
• 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: 8268859
• Report Number: 2124215-2019-00561
• Device Sequence Number: 2120551
• 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: 2014
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2022

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: 11/04/2015
• Device Model Number: K172
• Device Catalogue Number: K172
• Device Lot Number: 118717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2018
• Supplement Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 01/22/2019
• Supplement Report FDA Received Date: 04/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Sex: Female