MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALTRUA 40; IMPLANTABLE DEVICE

Model Number S403

Device Problem Use of Device Problem (1670)

Patient Problem No Code Available (3191)

Event Date 01/20/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The returned device was inspected and analyzed upon receipt at our post market quality assurance laboratory.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 pop up message stating 'measured data test not complete.' observations.

Event Description

It was reported that this patient underwent an explant procedure for this dual chamber pacemaker.It is unknown if the explanted device was replaced.The device was returned to boston scientific for analysis.This report is being filled as device evaluation was completed.No additional adverse patient effects were reported.

• Brand Name: ALTRUA 40
• Type of Device: IMPLANTABLE DEVICE
• 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: 11042385
• MDR Text Key: 222627035
• Report Number: 2124215-2020-22240
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526484445
• UDI-Public: 00802526484445
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N970003/S096
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/18/2020

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/07/2011
• Device Model Number: S403
• Device Catalogue Number: S403
• Device Lot Number: 578316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2020
• Initial Date FDA Received: 12/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 89 YR