MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALTRUA 2 DR; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number	S702
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Following completion of laboratory analysis, this event will be further updated.
Event or Problem Description
It was reported that the battery of this implantable device was suspected to be depleting prematurely.This device was replaced and returned to boston scientific for analysis is expected.Another boston scientific device was implanted without additional adverse incident.
Event or Problem Description
It was reported that the battery of this implantable device was suspected to be depleting prematurely.This device was replaced and returned to boston scientific for analysis.Another boston scientific device was implanted without additional adverse incident.
Additional Manufacturer Narrative
The returned pacemaker was inspected and analyzed 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.Note, the high power consumption is the result of the ventricle pacing output being programmed to 6.0 volts at varying pulse widths and matches theoretical models of power consumption when programmed to such levels.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 passed 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.

• Brand Name: ALTRUA 2 DR
• 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: 12139319
• Report Number: 2124215-2021-18248
• Device Sequence Number: 4424372
• Product Code: LWP
• UDI-Device Identifier: 00802526559341
• UDI-Public: 00802526559341
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: N970003/S167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 01/06/2022

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: 11/16/2021
• Device Model Number: S702
• Device Catalogue Number: S702
• Device Lot Number: 707653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2021
• Supplement Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 01/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2019
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown