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

Model Number	S702
Medical Device Problem Codes	Pacing Problem (1439); Device Sensing Problem (2917)
Health Effect - Clinical Codes	Syncope (1610); Cardiac Arrest (1762)
Date of Event	05/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Following return and completion of laboratory analysis, this event will be further updated.
Event or Problem Description
It was reported that this device had been implanted with normal parameters confirmed at implant and set in unipolar programming, as it was assumed the original device had been in unipolar.Due to the programming anomaly with the new device (unipolar vs bipolar programming) no pacing pulses were observed post connection.Approximately one month post implant, the patient was admitted for syncope and cardiac arrest.During system assessments post admission, the physician found interference signals.It was also learned the patient was very active with excessive upper limb movement during physician activity.A chest x-ray illustrated abnormal images of the lead at the collar bone.The associated implanted lead is a non boston scientific product.The physician elected to replace the entire system.The explanted device is expected to be returned.No information was provided on the associated lead manufacture or model/serial numbers.The replacement was successful and the issue resolved.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the device was performed.A visual inspection of the device header and case noted no anomalies; seal pugs were intact and setscrews operated normally.Pin gauge testing, designed to verify proper port dimensions, was completed.Each port measured as expected.The device was then exposed to simulated heart load conditions, and the pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.The device memory was also reviewed with no resets or faults observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.
Event or Problem Description
It was reported that this device had been implanted with normal parameters confirmed at implant and set in unipolar programming, as it was assumed the original device had been in unipolar.Due to the programming anomaly with the new device (unipolar vs bipolar programming) no pacing pulses were observed post connection.Approximately one month post implant, the patient was admitted for syncope and cardiac arrest.During system assessments post admission, the physician found interference signals.It was also learned the patient was very active with excessive upper limb movement during physician activity.A chest x-ray illustrated abnormal images of the lead at the collar bone.The associated implanted lead is a non boston scientific product.The physician elected to replace the entire system.The explanted device was returned.No information was provided on the associated lead manufacture or model/serial numbers.The replacement was successful and the issue resolved.

• 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: 8794055
• Report Number: 2124215-2019-13707
• Device Sequence Number: 16672967
• Product Code: LWP
• UDI-Device Identifier: 00802526559341
• UDI-Public: 00802526559341
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: N970003/S167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2019

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: Health Professional
• Device Expiration Date: 12/11/2020
• Device Model Number: S702
• Device Catalogue Number: S702
• Device Lot Number: 704831
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Initial Date Received by Manufacturer: 06/29/2019
• Supplement Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 07/16/2019
• Supplement Report FDA Received Date: 09/18/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening