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 Consequences Or Impact To Patient (2199)
Date of Event	04/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device has not been returned; therefore, a technical analysis cannot be conducted.Without a returned device it is not possible to definitively confirm how the device may have contributed to the complaint incident.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
Event or Problem Description
It was reported that the device battery had allegedly prematurely depleted.The device is pending explant to resolve the event at an unspecified future date.The patient was stable with no adverse consequences and no further information is available.
Event or Problem Description
It was reported that the device battery had allegedly prematurely depleted.The device was explanted and replaced to resolve the event.The patient was stable with no adverse consequences.
Event or Problem Description
It was reported that the device battery had allegedly prematurely depleted.The device was explanted and replaced to resolve the event.The patient was stable with no adverse consequences.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.A high current drain was detected.Detailed analysis confirmed that a high current drain was the result of a compromised capacitor, which resulted in the observed premature battery depletion.Investigation has determined that the high current drain is the result of compromised low voltage capacitors, which is caused by the presence of excess hydrogen from a liner component within the device.

• 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: 8718746
• Report Number: 2124215-2019-11658
• Device Sequence Number: 1821418
• Product Code: LWP
• UDI-Device Identifier: 00802526559341
• UDI-Public: 00802526559341
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: N970003/S167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/19/2020

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: 08/01/2016
• Device Model Number: S702
• Device Catalogue Number: S702
• Device Lot Number: 100044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2019
• Initial Date Received by Manufacturer: 04/17/2019
• Supplement Date Received by Manufacturer: 07/24/2019; 11/15/2019
• Initial Report FDA Received Date: 06/20/2019
• Supplement Report FDA Received Date: 10/28/2019; 01/19/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention