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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that this pacemaker and right ventricular (rv) lead exhibited high out-of-range pace impedance measurements greater than 2,500 ohms.Technical services (ts) recommended bringing the patient in clinic for device interrogation and rv lead evaluation.Additional information received indicated that the patient was seen in clinic for device interrogation and lead evaluation, and all measurements were satisfactory.The patient would continue to be monitored remotely.This pacemaker and rv lead remain in service.No adverse patient effects were reported.
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 this device exhibited intermittent fluctuations in impedance measurements with no conclusive evidence of a product malfunction; please refer to the description for more information regarding the specific circumstances of this event.
Event or Problem Description
It was reported that this pacemaker and right ventricular (rv) lead exhibited high out-of-range pace impedance measurements greater than 2,500 ohms.Technical services (ts) recommended bringing the patient in clinic for device interrogation and rv lead evaluation.Additional information received indicated that the patient was seen in clinic for device interrogation and lead evaluation, and all measurements were satisfactory.The patient would continue to be monitored remotely.This pacemaker and rv lead remain in service.No 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: 11704681
• Report Number: 2124215-2021-09450
• Device Sequence Number: 14207864
• Product Code: LWP
• UDI-Device Identifier: 00802526516818
• UDI-Public: 00802526516818
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: N970003/S132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2021

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: 06/19/2016
• Device Model Number: K172
• Device Catalogue Number: K172
• Device Lot Number: 121919
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 04/21/2021
• Supplement Report FDA Received Date: 07/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1