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

Model Number	S404
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that this pacemaker device had two years remaining battery longevity but hit end of life (eol) a few months later.Moreover, this device was explanted and replaced.No additional adverse patient effects reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, a review of the device memory noted no resets, errors, or fault codes.Manual electrical measurements noted normal sensing and pacemaker functions.The device is not currently operating near a bin edge.The device passes longevity calculations at 82%.Analysis found no evidence of device defect, malfunction or damage outside the bounds of normal medical use.
Event or Problem Description
It was reported that this pacemaker device had two years remaining battery longevity but hit end of life (eol) a few months later.Moreover, this device was explanted and replaced.The device was then returned to laboratory and was analyzed.No additional adverse patient effects 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 12271792
• Report Number: 2124215-2021-22544
• Device Sequence Number: 4225487
• Product Code: LWP
• UDI-Device Identifier: 00802526484452
• UDI-Public: 00802526484452
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: N970003/S106
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2022

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: 11/11/2012
• Device Model Number: S404
• Device Catalogue Number: S404
• Device Lot Number: 597022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2021
• Supplement Date Received by Manufacturer: 03/02/2022
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 04/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2010
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female