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

Model Number	S403
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	07/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
Event or Problem Description
Boston scientific received information that previously this pacemaker showed one year remaining longevity.After 5 months, the device showed less than six months remaining longevity.Boston scientific technical services (ts) offered to review memory dump and save to diskette if desired.The patient will be seen again in three months.As of this time, the device remains in service.No adverse patient effects reported.
Event or Problem Description
Boston scientific received information that previously this pacemaker showed one year remaining longevity.After 5 months, the device showed less than six months remaining longevity.Boston scientific technical services (ts) offered to review memory dump and save to diskette if desired.The patient will be seen again in three months.As of this time, the device remains in service.No adverse patient effects reported.Additional information obtained from the field which indicated that the device was explanted due to normal battery depletion (nbd).No additional adverse patient effects were reported.
Additional Manufacturer Narrative
The returned device was analyzed.A visual inspection of the device header and case noted no anomalies.Pin gauge testing, designed to verify proper port dimensions, was completed.Each port measured as expected.The device was then exposed to simulated heart load conditions, and the pacing, and sensing functions were tested.Impedance testing was completed, and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.
Additional Manufacturer Narrative
The returned device was analyzed.A visual inspection of the device header and case noted no anomalies.Pin gauge testing, designed to verify proper port dimensions, was completed.Each port measured as expected.The device was then exposed to simulated heart load conditions, and the pacing, and sensing functions were tested.Impedance testing was completed, and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.This report is being filed to correct the adverse event or product problem and adverse event/product problem, initial reporter and initial reporter first name, initial reporter last name, initial reporter address 1, device manufacturers only and type of reportable event, device manufacturers only and patient code.
Event or Problem Description
Boston scientific received information that previously this pacemaker showed one year remaining longevity.After 5 months, the device showed less than six months remaining longevity.Boston scientific technical services (ts) offered to review memory dump and save to diskette if desired.The patient will be seen again in three months.As of this time, the device remains in service.No adverse patient effects reported.Additional information obtained from the field which indicated that the device was explanted due to normal battery depletion (nbd).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: 8597557
• Report Number: 2124215-2019-09678
• Device Sequence Number: 2075113
• Product Code: LWP
• UDI-Device Identifier: 00802526484445
• UDI-Public: 00802526484445
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/30/2020

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: 09/19/2013
• Device Model Number: S403
• Device Catalogue Number: S403
• Device Lot Number: 588751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Initial Date Received by Manufacturer: 01/23/2019
• Supplement Date Received by Manufacturer: 01/30/2020; 01/30/2020
• Initial Report FDA Received Date: 05/09/2019
• Supplement Report FDA Received Date: 04/25/2020; 04/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 78 YR