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

Model Number	S403
Medical Device Problem Codes	Premature Discharge of Battery (1057); Defective Device (2588)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No further information concerning this report is currently available.This investigation will be updated should further information be provided.
Event or Problem Description
It was reported that over the last six months this pacemaker has been experiencing fluctuating magnet rates and is near ert.The device was then explanted due to a product performance issue and replaced.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, an engineering-level longevity prediction calculation was completed to assess the rate of battery depletion.Given the programmed parameters and other data stored within the memory of the device, the results of this calculation indicated that the actual rate of battery depletion fell within an acceptable range.Next, a series of diagnostic tests were conducted that verified the performance of pacing, sensing, and recording functions.Having met the engineering longevity prediction, functionally passing all returned product testing, and with no further information to indicate a product performance issue, we have concluded that this device experienced normal battery depletion.
Event or Problem Description
This supplemental report is being filled to include device analysis information.
Additional Manufacturer Narrative
This product is returned for analysis.This report will be updated upon return and completion of analysis.
Event or Problem Description
It was reported that this device was explanted due to premature battery depletion.This device was explanted and returned for analysis.No additional adverse patient effects were reported.

• 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: 8324096
• Report Number: 2124215-2019-03193
• Device Sequence Number: 13834823
• Product Code: LWP
• UDI-Device Identifier: 00802526484445
• UDI-Public: 00802526484445
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: N970003/S096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/21/2019

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: 06/15/2013
• Device Model Number: S403
• Device Catalogue Number: S403
• Device Lot Number: 587327
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/28/2018
• Supplement Date Received by Manufacturer: 02/13/2019; 06/12/2019
• Initial Report FDA Received Date: 02/08/2019
• Supplement Report FDA Received Date: 05/06/2019; 06/21/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention