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 Codes	Dizziness (2194); Syncope/Fainting (4411)
Date of Event	02/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this pacemaker recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.The patient experienced dizziness and fainting.Subsequently, this device was explanted and replaced.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
The returned pacemaker was analyzed and an engineering-level longevity prediction calculation was completed to assess the rate of battery depletion.Memory review noted that no fault code 1003 was recorded within the device memory.The fault code 1003 issued by the programmer noted at explant was due to the device being at bex which will put the device into storage mode.This red warning screen only occurs when a device is in storage mode.The battery voltage was low at bex which is why the programmer issued the warning.This was not due to a device malfunction.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.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: 14067540
• Report Number: 2124215-2022-09395
• Device Sequence Number: 11989570
• Product Code: LWP
• UDI-Device Identifier: 00802526559341
• UDI-Public: 00802526559341
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: N970003/S167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/09/2022

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: 08/12/2017
• Device Model Number: S702
• Device Catalogue Number: S702
• Device Lot Number: 700337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2022
• Initial Report FDA Received Date: 04/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2015
• 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: Female