MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALTRUA 60; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number S606

Device Problems Unexpected Therapeutic Results (1631); Use of Device Problem (1670)

Patient Problems Dyspnea (1816); Syncope/Fainting (4411); Unspecified Heart Problem (4454)

Event Date 11/01/2021

Event Type  Injury  

Event Description

It was reported that the patient presented to the clinic for a scheduled follow up.It was reported that this pacemaker had reached elective replacement indicator (eri) 4 months ago, and then reached end of life (eol) 8 days before the in clinic follow up.The device was operating at vvi 50.The patient experienced shortness of breath (sob) and palpitations.The physician scheduled device replacement to take place 2 weeks later.The patient contacted technical services (ts) and expressed concern for therapy availability.Ts discussed therapy cannot be guaranteed at eol and recommended device replacement as soon as possible.Subsequently, the patient presented to the hospital 6 days later after experiencing 2 syncopal episodes.The patient was admitted to the hospital, and device replacement was undertaken 4 days later.The device was explanted and replaced.No additional adverse patient effects were reported.At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.

• Brand Name: ALTRUA 60
• 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: 14152754
• MDR Text Key: 289692633
• Report Number: 2124215-2022-12050
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526484490
• UDI-Public: 00802526484490
• Combination Product (y/n): N
• PMA/PMN Number: N970003/S106
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/08/2013
• Device Model Number: S606
• Device Catalogue Number: S606
• Device Lot Number: 161003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2011
• 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): Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male