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

Model Number	K062
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/20/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this pacemaker device exhibited premature battery depletion behavior.Boston scientific engineering analysis of device data confirmed that the power consumption of this device has been increasing in a gradual fashion.The analysis also indicated that based on conservative modeling, the device will not deplete to the elective replacement indicator (eri) battery status before the 90 day eri to end of life (eol) time.Boston scientific technical services (ts) provided the analysis results to the healthcare provider (hcp) and indicated they will send a message to the local boston scientific representative (rep).The device remains in service at this time.No adverse patient effects were reported.

• Brand Name: ADVANTIO
• Common Device Name: IMPLANTABLE DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 11105064
• Report Number: 2124215-2020-27160
• Device Sequence Number: 676971
• Product Code: LWP
• UDI-Device Identifier: 00802526516658
• UDI-Public: 00802526516658
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: N970003/S132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/02/2021

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: 08/05/2014
• Device Model Number: K062
• Device Catalogue Number: K062
• Device Lot Number: 112860
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2020
• Initial Report FDA Received Date: 01/02/2021
• Patient Sequence Number: 1
• Patient Age: 80 YR