MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALTRUA 20; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number	S201
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this device declared end of life (eol).At the beginning of this year, the battery longevity showed two years remaining, with only 8% pacing.The device had first declared elective replacement indicator (eri) last month, and then recently declared eol.Subsequently, this device was explanted and replaced.No additional adverse patient effects were reported.This device is expected for return.
Event or Problem Description
It was reported that this implantable device declared end of life (eol).At the beginning of this year, the battery longevity showed two years remaining, with only 8% pacing.The device had first declared elective replacement indicator (eri) last month, and then recently declared eol.Subsequently, this device was explanted and replaced.No additional adverse patient effects were reported.This device was received for analysis.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, detailed mechanical and electrical testing was performed on the device.The device functioned normally throughout testing.Laboratory analysis determined that this device experienced normal battery depletion; however, it was reported from the field that the estimated longevity remaining value appeared to decrease more quickly than expected between routine follow-ups.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 note that, despite the drop in estimated longevity remaining, the actual battery condition did not change significantly between follow-ups.In summary, it was determined that this device experienced normal battery depletion, but declared eol earlier than previously estimated.

• Brand Name: ALTRUA 20
• 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: 12619381
• Report Number: 2124215-2021-24366
• Device Sequence Number: 3586368
• Product Code: LWP
• UDI-Device Identifier: 00802526484384
• UDI-Public: 00802526484384
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: N970003/S096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2021

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: 08/05/2011
• Device Model Number: S201
• Device Catalogue Number: S201
• Device Lot Number: 102946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/07/2021
• Supplement Date Received by Manufacturer: 11/17/2021
• Initial Report FDA Received Date: 10/12/2021
• Supplement Report FDA Received Date: 12/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2009
• 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 Sex: Male