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

Model Number	S208
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Codes	Syncope (1610); Palpitations (2467)
Date of Event	04/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 this patient presented for evaluation due to palpitations and syncope.No episodes were stored on the device during the period of the reported syncope.Boston scientific technical services suggested that the patient follow up with their cardiologist.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this patient presented for evaluation due to palpitations and syncope.No episodes were stored on the device during the period of the reported syncope.Boston scientific technical services suggested that the patient follow up with their cardiologist.No additional adverse patient effects were reported.Additional information was received in which it was reported that this pacemaker was later explanted due to normal battery depletion (nbd).
Additional Manufacturer Narrative
The returned device was inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.Pacing and sensing functions were tested and the device was verified to operate as expected.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.

• 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: 8722461
• Report Number: 2124215-2019-12289
• Device Sequence Number: 1685618
• Product Code: LWP
• UDI-Device Identifier: 00802526484421
• UDI-Public: 00802526484421
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: N970003/S106
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2020

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: 11/08/2012
• Device Model Number: S208
• Device Catalogue Number: S208
• Device Lot Number: 595706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Initial Date Received by Manufacturer: 04/28/2019
• Supplement Date Received by Manufacturer: 09/10/2020
• Initial Report FDA Received Date: 06/21/2019
• Supplement Report FDA Received Date: 10/23/2020
• 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; Life Threatening
• Patient Age: 35 YR