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

Model Number	K062
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438); Defective Device (2588); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/17/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this pacemaker and a non-boston scientific right ventricular (rv) lead exhibited threshold measurement issues.The last measured threshold measurement was above the outputs.There were two beats of loss of capture noted.Additionally, there were stored episodes of rv noise, oversensing, and greater than two seconds of pacing inhibition.Further, technical services (ts) noted episodes of noise which were related to the minute ventilation (mv) feature, but this noise was not being oversensed.It was discussed with the healthcare professional (hcp) that this rv lead should be evaluated, and the hcp was going to discuss further with the physician.No adverse patient effects were reported.The device remains in service.
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.Investigation of the available information also determined this device exhibited oversensing of noise generated by the minute ventilation (mv)/respiratory sensor that is related to a high impedance condition.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 a non-boston scientific right ventricular (rv) lead exhibited threshold measurement issues.The last measured threshold measurement was above the outputs.There were two beats of loss of capture noted.Additionally, there were stored episodes of rv noise, oversensing, and greater than two seconds of pacing inhibition.Further, technical services (ts) noted episodes of noise which were related to the minute ventilation (mv) feature, but this noise was not being oversensed.It was discussed with the health care professional (hcp) that this rv lead should be evaluated, and the hcp was going to discuss further with the physician.No adverse patient effects were reported.The device remains in service.

• Brand Name: ADVANTIO
• 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: 11042432
• Report Number: 2124215-2020-25244
• Device Sequence Number: 1087451
• Product Code: LWP
• UDI-Device Identifier: 00802526516658
• UDI-Public: 00802526516658
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: N970003/S132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2021

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: 07/01/2015
• Device Model Number: K062
• Device Catalogue Number: K062
• Device Lot Number: 117756
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/03/2020
• Supplement Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 12/18/2020
• Supplement Report FDA Received Date: 01/05/2021
• Patient Sequence Number: 1
• Patient Age: 89 YR