MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INGENIO; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number	K172
Medical Device Problem Codes	High impedance (1291); Over-Sensing (1438); Pacing Problem (1439); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
Event or Problem Description
It was reported that the right ventricular (rv) lead connected to this device was surgically abandoned and replaced due to pacing impedances greater than 2000 ohms, noise, oversensing, and pacing inhibition.No additional adverse patient effects were reported.This device remains in service with the new lead.
Additional Manufacturer Narrative
This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that there was no conclusive evidence that the observed out-of-range impedance measurements were due to a malfunction or an inadequate lead-to-device connection.
Event or Problem Description
This report is being filed as the evaluation result codes, evaluation conclusion code, and additional manufacturer narrative have been updated.

• Brand Name: INGENIO
• Common Device Name: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8759368
• Report Number: 2124215-2019-12811
• Device Sequence Number: 16564110
• Product Code: LWP
• UDI-Device Identifier: 00802526516818
• UDI-Public: 00802526516818
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: N970003/S132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2019

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: 07/03/2016
• Device Model Number: K172
• Device Catalogue Number: K172
• Device Lot Number: 122178
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/04/2019
• Supplement Date Received by Manufacturer: 09/11/2019
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 10/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 88 YR