MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALTRUA 20; IMPLANTABLE DEVICE

Model Number	S208
Medical Device Problem Codes	Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested to the representative.No further information concerning this report is available at this time.This investigation will be updated should further pertinent information be provided.(b)(4).No field allegations against this device.Additional information has been requested to the representative.
Event or Problem Description
It was reported that this device was explanted due to unknown reasons.The entire system was removed from service.This device apparently exhibited a malfunction.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this device was explanted due to unknown reasons.The entire system was removed from service.This device apparently exhibited a malfunction.No additional adverse patient effects were reported.The product was returned for analysis.
Additional Manufacturer Narrative
The returned device was inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.Pin gauge testing, designed to verify proper port dimensions, was completed.Each port measured as expected.Pacing and sensing functions were tested and the device was verified to operate as expected.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.Patient code 3191 captures the reportable event of surgery.

• Brand Name: ALTRUA 20
• Common Device Name: IMPLANTABLE DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 10329556
• Report Number: 2124215-2020-15585
• Device Sequence Number: 1045347
• Product Code: LWP
• UDI-Device Identifier: 00802526484421
• UDI-Public: 00802526484421
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: N970003/S106
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2021

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: 05/31/2013
• Device Model Number: S208
• Device Catalogue Number: S208
• Device Lot Number: 597348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2020
• Initial Date Received by Manufacturer: 06/22/2020
• Supplement Date Received by Manufacturer: 01/22/2021
• Initial Report FDA Received Date: 07/27/2020
• Supplement Report FDA Received Date: 01/25/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR