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

Model Number	S702
Medical Device Problem Codes	Over-Sensing (1438); Pacing Problem (1439); Device Sensing Problem (2917); High Capture Threshold (3266)
Health Effect - Clinical Code	Syncope (1610)
Date of Event	03/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Should additional information be received, another report will be submitted.
Event or Problem Description
It was reported that the patient with this device system will likely be scheduled for replacement due to jumpy unresolved, impedance measurements.The field representative reported the patient also has several, unidentified, abandoned implanted leads.During the recent follow-up, noise on the right atrial lead was observed during an interrogation session.Additionally, two syncope events occurred within the past three weeks; dates/times unknown.The patient was hospitalized following the first syncope; surface electrogram was without abnormalities.The device was then reprogrammed to turn off the amv sensor and the patient released.The second syncope illustrated a ventricular rhythm below the lower rate limit.Av block iii was present on surface ecg in hospital.Ventricular rhythm of 26 bpm.Again, the interrogation of device was without abnormalities and showed proper threshold.Oversensing was assumed as cause for stimulation inhibition: reprogramming, rv sensitivity set to 4.0 v with proper rv sensing.Field follow up has confirmed the system, device and active leads, will be explanted and replaced at a later date and, at another medical facility.The patient is currently on holiday.

• 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: 8562544
• Report Number: 2124215-2019-07983
• Device Sequence Number: 2294230
• Product Code: LWP
• UDI-Device Identifier: 00802526559341
• UDI-Public: 00802526559341
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: N970003/S167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/29/2019

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: Health Professional
• Device Expiration Date: 07/08/2017
• Device Model Number: S702
• Device Catalogue Number: S702
• Device Lot Number: 700105
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2019
• Initial Report FDA Received Date: 04/29/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening