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

Model Number	S404
Medical Device Problem Codes	Signal Artifact/Noise (1036); Low impedance (2285); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Please refer to b5 describe event or problem for more information regarding the specific circumstances of this event.
Event or Problem Description
It was reported that the patient with this pacemaker was seen in-clinic for a routine follow up.Upon device inspection, several v-tachy episodes were recorded.Additional testing was performed to reproduce noise with aggressive isometrics, palpating the device etc.But no noise was noted.Data analysis was provided to boston scientific technical services for review and noise was confirmed.Boston scientific technical services recommended to continue monitoring this patient via latitude home monitoring system.No adverse patient effects were reported.This device remains in service.Additional information was provided on 07sep2021, it was reported that the patient with this pacemaker was seen in-clinic for right ventricular (rv) monitoring.The rv pacing impedance showed a decrease to 120 ohms and an rv threshold increased.There was no asystole and no symptoms consistent with loss of capture documented by the patient.The device was reprogrammed.The patient will be scheduled for a new rv lead in the coming months.No adverse patient effects were reported.This pacemaker and competitor rv lead remains in-service.

• 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
• MDR Report Key: 12749669
• Report Number: 2124215-2021-34189
• Device Sequence Number: 14682741
• Product Code: LWP
• UDI-Device Identifier: 00802526484452
• UDI-Public: 00802526484452
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/03/2021

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: Lay User/Patient
• Device Expiration Date: 02/28/2014
• Device Model Number: S404
• Device Catalogue Number: S404
• Device Lot Number: 600035
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 11/03/2021
• Patient Sequence Number: 1