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

Model Number	S702
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned and is undergoing laboratory analysis.This report will be updated when analysis is complete.
Event or Problem Description
It was reported that this boxed device was interrogated as part of china's customs process for receiving medical devices.Upon interrogation, the device was found to be in safety core status.An error screen was submitted to technical services for review and it was determined a memory error had occurred.The device was returned for analysis.
Additional Manufacturer Narrative
The device was returned and is undergoing laboratory analysis.This report will be updated when analysis is complete.Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the device was performed.The device was confirmed to be in safety mode.Review of stored memory found that the device had experienced several faults related to corrupted data within the device memory.The device was reset back to primary operation and was exposed to cooler temperatures.This caused the device to revert to safety mode operation, due to the same faults.The device case was removed so the internal components could be inspected and tested.The digital ic (integrated circuit) was removed from the circuit board and inserted onto a new circuit board and connected to the device.The device was again reset back to primary operation and was exposed to cooler temperatures.Again, the device reverted to safety mode with the same faults observed.Laboratory analysis determined the device reverted to safety mode operation due to a failed component within the digital ic.The cause of the component failure could not be determined.
Event or Problem Description
It was reported that this boxed device was interrogated as part of china's customs process for receiving medical devices.Upon interrogation, the device was found to be in safety core status.An error screen was submitted to technical services for review and it was determined a memory error had occurred.The device was returned for analysis.

• 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
• MDR Report Key: 8584577
• Report Number: 2124215-2019-09025
• Device Sequence Number: 14208197
• 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
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 12/19/2020
• Device Model Number: S702
• Device Catalogue Number: S702
• Device Lot Number: 704994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2019
• Initial Date Received by Manufacturer: 03/19/2019
• Supplement Date Received by Manufacturer: 08/15/2019
• Initial Report FDA Received Date: 05/06/2019
• Supplement Report FDA Received Date: 09/26/2019
• Patient Sequence Number: 1