MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALTRUA 20; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number S209

Device Problem Defective Device (2588)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 10/02/2019

Event Type  malfunction  

Manufacturer Narrative

Information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

It was reported that the patient implanted with this pacemaker does not feel well.The patient attempted to get their device check but their local physician did not have a programmer available.Boston scientific technical services (ts) provided accounts in the area that have programmers available to interrogate the device.Attempts to obtain additional information was unsuccessful.

• Brand Name: ALTRUA 20
• Type of Device: 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: 9540791
• MDR Text Key: 173771135
• Report Number: 2124215-2019-25621
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: AR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/13/2014
• Device Model Number: S209
• Device Catalogue Number: S209
• Device Lot Number: 595062
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 90 YR