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 Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	12/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that this device exhibited premature battery depletion.A request was made to have data from this device analyzed, and a technical services (ts) consultant recommended device replacement.Subsequently, the patient underwent a revision procedure, and this device was explanted and replaced.No additional adverse patient effects were reported.
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 the 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.Boston scientific has issued an advisory communication regarding a subset of pacemakers in the accolade product family that has an elevated potential of exhibiting this behavior.This device is not part of the hydrogen induced premature depletion advisory population.
Event or Problem Description
It was reported that this device exhibited premature battery depletion.A request was made to have data from this device analyzed, and a technical services (ts) consultant recommended device replacement.Subsequently, the patient underwent a revision procedure, and this device was explanted and replaced.No additional adverse patient effects were reported.Additional information: the device has been returned and analysis has been completed.This report has been updated with the product investigation results.

• 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: 9550719
• Report Number: 2124215-2019-27390
• Device Sequence Number: 2133286
• 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: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2020

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: 07/20/2017
• Device Model Number: S702
• Device Catalogue Number: S702
• Device Lot Number: 700224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Initial Date Received by Manufacturer: 12/18/2019
• Supplement Date Received by Manufacturer: 01/31/2020
• Initial Report FDA Received Date: 01/06/2020
• Supplement Report FDA Received Date: 03/26/2020
• 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; Other; Required Intervention