MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALTRUA 20; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number	S208
Medical Device Problem Codes	Defective Device (2588); Interrogation Problem (4017)
Health Effect - Clinical Codes	Syncope (1610); Chest Pain (1776); Fall (1848); No Code Available (3191)
Date of Event	05/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time, the device has been returned but evaluation is not yet complete.This record will be updated upon completion of evaluation or receipt of additional information.(b)(4).
Event or Problem Description
It was reported that this patient presented to the emergency room after what appeared to be a syncopal episode.The patient fell during the episode.Cardiopulmonary resuscitation (cpr) was performed and an external defibrillator was applied to the patient.However, the external defibrillator did not detect a treatable rhythm and no shock was delivered.The health care provider experienced some difficulty interrogating the patient's device, but a boston scientific representative was able to complete the interrogation.The device had not stored any episodes on the day of the syncope.Subsequently, the patient's device was explanted.It was noted that the device had been active for greater than 9 years and may have been reaching the end of its battery life.It was noted that the patient experienced some chest pain associated with the cpr, but no further adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the device was performed.A visual inspection of the device header and case noted body fluid contamination in the lead barrels, but no further anomalies.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.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.Inclusion of the patient code 3191 indicates that this patient received cardiopulmonary resuscitation during this event.
Event or Problem Description
This report is being filed as device evaluation has been completed.

• Brand Name: ALTRUA 20
• 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: 8860703
• Report Number: 2124215-2019-16153
• Device Sequence Number: 617535
• Product Code: LWP
• UDI-Device Identifier: 00802526484421
• UDI-Public: 00802526484421
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: N970003/S106
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2019

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: Lay User/Patient
• Device Expiration Date: 12/08/2012
• Device Model Number: S208
• Device Catalogue Number: S208
• Device Lot Number: 595843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Initial Date Received by Manufacturer: 05/09/2019
• Supplement Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 08/05/2019
• Supplement Report FDA Received Date: 09/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 67 YR