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

Model Number	K172
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/10/2018
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 pacing impedances on the right ventricular (rv) lead connected to this pacemaker were trending upwards and reached greater than 2000 ohms on (b)(6) 2018.This resulted in an automatic safety switch to unipolar.The patient was evaluated in clinic; this device then was programmed to pace in the ventricle only with no response to sensing and the patient was referred for lead revision.Subsequently, the rv lead was surgically abandoned and replaced.This pacemaker remains in service with the new rv lead.No additional adverse patient effects were reported.

• 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: 8250554
• Report Number: 2124215-2019-00187
• Device Sequence Number: 2189859
• Product Code: LWP
• UDI-Device Identifier: 00802526516818
• UDI-Public: 00802526516818
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Report Date (Section B): 01/15/2019

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: 07/18/2016
• Device Model Number: K172
• Device Catalogue Number: K172
• Device Lot Number: 122367
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2018
• Initial Report FDA Received Date: 01/15/2019
• 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