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

Model Number	S722
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this pacemaker was suspected to be exhibiting premature battery depletion.A save to disk was sent in for engineering analysis and it was confirmed that there was an increase in power consumption.Boston scientific technical services recommended device replacement because of this anomaly.No adverse patient effects were reported.This device remains in service.
Additional Manufacturer Narrative
This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Please refer to b5 describe event or problem for more information regarding the specific circumstances of this event.
Event or Problem Description
It was reported that this pacemaker was suspected to be exhibiting premature battery depletion.A save to disk was sent in for engineering analysis and it was confirmed that there was an increase in power consumption.Boston scientific technical services recommended device replacement because of this anomaly.Subsequently, this device was explanted and replaced with a competitor device.No additional adverse patient effects were reported.

• Brand Name: ALTRUA 2 EL 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: 13329640
• Report Number: 2124215-2021-40104
• Device Sequence Number: 13864738
• Product Code: LWP
• UDI-Device Identifier: 00802526559365
• UDI-Public: 00802526559365
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: N970003/S167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2022

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: 10/21/2017
• Device Model Number: S722
• Device Catalogue Number: S722
• Device Lot Number: 700094
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/08/2021
• Supplement Date Received by Manufacturer: 01/28/2022
• Initial Report FDA Received Date: 01/22/2022
• Supplement Report FDA Received Date: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown