MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALTRUA 40; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number	S404
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report will be updated should additional information be provided.
Event or Problem Description
It was reported during ongoing use, premature battery depletion was observed.The patients device has been depleting at approximately 2x the stated rate.The longevity reduced by two years in one year's time.The patient was seen in clinic last year and was quoted 2.5 years battery remaining, and is now quoted at less than 6 months remaining.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 battery status indicators were different than expected based on information provided to boston scientific.Factors influencing the estimated longevity remaining calculation include pacing rate, amplitude, pulse-width and lead impedance.Any (even slight) changes in these factors will impact the battery consumption calculation and therefore the remaining longevity estimate.Please refer to the description for more information regarding the specific circumstances of this event.
Event or Problem Description
It was reported that premature battery depletion was suspected.It was observed that this device has been depleting at approximately two times the stated rate.The battery longevity decreased by two years, within one year's time.The patient was seen in clinic last year, and was told that there was 2.5 years of battery remaining.However, recently the battery showed less than 6 months remaining.A boston scientific technical services consultant reviewed device data, and discussed that the rate of depletion, and overall longevity suggest normal device operation.The longevity is updating to reflect the current usage whether there is an increase or a decrease in longevity.It's reflective of the actual current usage.This device remains implanted.No adverse patient effects were reported.Additional information: several requests were submitted to the field to obtain further information; however, there was no response received.

• Brand Name: ALTRUA 40
• 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: 10236568
• Report Number: 2124215-2020-12014
• Device Sequence Number: 11561916
• Product Code: LWP
• UDI-Device Identifier: 00802526484452
• UDI-Public: 00802526484452
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: N970003/S106
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare 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: 11/02/2013
• Device Model Number: S404
• Device Catalogue Number: S404
• Device Lot Number: 599244
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/03/2020
• Supplement Date Received by Manufacturer: 11/06/2020
• Initial Report FDA Received Date: 07/06/2020
• Supplement Report FDA Received Date: 01/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1