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

Model Number	S702
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.A high current drain was detected, but the battery still supported full device function.Detailed analysis confirmed the identified high current drain was a result of compromised capacitors.This resulted in the observed premature battery depletion.It was determined that the capacitors were compromised due to the presence of excess hydrogen in the device case.Boston scientific has issued a field safety notice regarding a subset of pacemakers in the accolade product family that has an elevated potential of exhibiting this behavior.This particular device was not included in the hydrogen induced premature depletion advisory population.However, this capacitor behavior can still occur in non-advisory devices.
Event or Problem Description
It was reported that this pacemaker was implanted for less than five years.Premature battery depletion was suspected and the device was explanted and replaced.No additional adverse patient effects were reported.The explanted device was expected to be returned for analysis.

• 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: 11128128
• Report Number: 2124215-2020-27687
• Device Sequence Number: 608017
• Product Code: LWP
• UDI-Device Identifier: 00802526559341
• UDI-Public: 00802526559341
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: N970003/S167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/06/2021

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: 06/11/2017
• Device Model Number: S702
• Device Catalogue Number: S702
• Device Lot Number: 700059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 01/06/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention