MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALTRUA 40; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number	S404
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Loss of consciousness (2418); Syncope/Fainting (4411); Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	04/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this pacemaker was admitted to the hospital due to congestive heart failure and severe neck pain.While in the hospital, a pacemaker check was performed.During pace threshold testing, the patient went rigid, their limbs spasmed, and the patient was unable to speak for several minutes.It was thought that the test appeared to stop the patient's heartbeat.The test was cancelled and the patient recovered.The patient was discharged from the hospital several days later and was placed on hospice care.No additional adverse patient effects were reported.The device remains in service.The local area sales representative was contacted for additional information.At this time, no further information is available.Should additional information become available this report will be updated.
Event or Problem Description
It was reported that the patient with this pacemaker was admitted to the hospital due to congestive heart failure and severe neck pain.While in the hospital, a pacemaker check was performed.During pace threshold testing, the patient went rigid, their limbs spasmed, and the patient was unable to speak for several minutes.It was thought that the test appeared to stop the patient's heartbeat.The test was cancelled and the patient recovered.The patient was discharged from the hospital several days later and was placed on hospice care.No additional adverse patient effects were reported.The device remains in service.The local area sales representative was contacted for additional information.At this time, no further information is available.Should additional information become available this report will be updated.Additional information was received which indicated that the previously reported pace threshold test that was performed had been stopped, and then the patient became syncopal.There was no indication of the patient's limbs spasming or additional symptoms other than syncope.The healthcare staff was alerted to the syncope.Pace threshold testing was performed again the following day with no further issues reported.No additional adverse patient effects were reported.The device remains in service.The local area sales representative was contacted for additional information.At this time, no further information is available.Should additional information become available this report will be updated.

• Brand Name: ALTRUA 40
• Common Device Name: 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: 14644430
• Report Number: 2124215-2022-20517
• Device Sequence Number: 11978753
• Product Code: LWP
• UDI-Device Identifier: 00802526484452
• UDI-Public: 00802526484452
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: N970003/S106
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2022

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: 01/23/2014
• Device Model Number: S404
• Device Catalogue Number: S404
• Device Lot Number: 599691
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2022
• Supplement Date Received by Manufacturer: 04/19/2022
• Initial Report FDA Received Date: 06/09/2022
• Supplement Report FDA Received Date: 06/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 86 YR
• Patient Sex: Male