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

Model Number	S603
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439)
Health Effect - Clinical Code	Asystole (4442)
Date of Event	06/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a battery replacement procedure, noise with oversensing was observed with electrocautery use and it was noted that "the pulse seems to have extended".It was noted that the patient had an intrinsic heart rate of 50 bpm and the device was programmed to vvi 40.Additional information received clarified that there was pacing inhibition with greater than two seconds of asystole as well as pacing delivered when not required.The observed behavior stopped when electrocautery was stopped.The pacemaker was explanted and replaced.No adverse patient effects were reported.The pacemaker will be returned for analysis.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.During testing, no noise was noted on the electrograms and event markers.The device was then exposed to simulated heart load conditions, and the pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.The altrua system guide states "electrosurgical cautery could induce ventricular arrhythmias and/or fibrillation, may cause asynchronous or inhibited pacemaker operation, or may trigger the eol indicator.".
Event or Problem Description
It was reported that during a battery replacement procedure, noise with oversensing was observed with electrocautery use and it was noted that "the pulse seems to have extended".It was noted that the patient had an intrinsic heart rate of 50 bpm and the device was programmed to vvi 40.Additional information received clarified that there was pacing inhibition with greater than two seconds of asystole as well as pacing delivered when not required.The observed behavior stopped when electrocautery was stopped.The pacemaker was explanted and replaced.No adverse patient effects were reported.The pacemaker will be returned for analysis.Additional information received reported that this pacemaker was returned for analysis.

• Brand Name: ALTRUA 60
• 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: 15003803
• Report Number: 2124215-2022-25454
• Device Sequence Number: 16614559
• Product Code: LWP
• UDI-Device Identifier: 00802526484483
• UDI-Public: 00802526484483
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: N970003/S096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/08/2016
• Device Model Number: S603
• Device Catalogue Number: S603
• Device Lot Number: 970427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2022
• Supplement Date Received by Manufacturer: 08/09/2022
• Initial Report FDA Received Date: 07/13/2022
• Supplement Report FDA Received Date: 08/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2014
• 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
• Patient Sex: Unknown