MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALTRUA 2 DR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	S702
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/18/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this pacemaker is behaving in a manner consistent with a recorded code 1003 indicative of premature battery depletion.Device was explanted and replaced.No additional adverse patient effects were reported.At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.A longevity calculation was completed and confirmed this device did not last as long as expected.Additionally, a high current drain was detected.Detailed analysis confirmed the identified high current drain was a result of a leaky capacitor.Investigation determined that the premature battery depletion was caused by the presence of excess hydrogen in the device case, and the source of the hydrogen was a liner component within the device.
Event or Problem Description
It was reported that this pacemaker is behaving in a manner consistent with a recorded code 1003 indicative of premature battery depletion.Device was explanted and replaced.No additional adverse patient effects were reported.Boston scientific received device and completed analysis.

• Brand Name: ALTRUA 2 DR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8505087
• Report Number: 2124215-2019-03550
• Device Sequence Number: 10812544
• 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
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2019

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: 07/20/2017
• Device Model Number: S702
• Device Catalogue Number: S702
• Device Lot Number: 700247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2019
• Initial Date Received by Manufacturer: 01/21/2019
• Supplement Date Received by Manufacturer: 06/04/2019
• Initial Report FDA Received Date: 04/11/2019
• Supplement Report FDA Received Date: 07/03/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention