MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALTRUA 2 DR; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number	S702
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438)
Health Effect - Clinical Code	Syncope (1610)
Date of Event	01/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This investigation is ongoing.Upon additional information this investigation will be updated.
Event or Problem Description
It was reported that the patient was admitted to the hospital due to syncope and was foaming at the mouth.It was noted that the same day there was an episode of noise and oversensing on the ventricular electrocardiogram.The noise was able to be reproduced with manipulation, however no oversensing was seen.It was noted that the signal amplitudes had decreased on the ventricular electrocardiogram.Possible lead damage was suspected but not confirmed.The lead model/serial was not obtained.A review of the case by technical services (ts) confirmed noise, although the root cause was not clear.Oversensing was also seen, although the patient had an intrinsic rhythm, thus no asystole was seen.Ts discussed noise which was seen in the two episodes sent in for review potentially related to mechanical impairment as well as myopotential or background noise.In addition it was noted that there was a fluctuation in pace impedance measurements, but values were within range.Ts discussed performing additional maneuvers to determine the root cause of this case.Additional information noted that the physician performed the suggested steps by technical services and believed that the noise was myopotential interference.The patient was discharged.

• Brand Name: ALTRUA 2 DR
• 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: 9926874
• Report Number: 2124215-2020-03318
• Device Sequence Number: 3218379
• Product Code: LWP
• UDI-Device Identifier: 00802526559341
• UDI-Public: 00802526559341
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: N970003/S167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/05/2020

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: 10/26/2020
• Device Model Number: S702
• Device Catalogue Number: S702
• Device Lot Number: 704470
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 04/05/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening