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

Model Number	S702
Medical Device Problem Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Codes	Discomfort (2330); Complete Heart Block (2627); Heart Block (4444)
Date of Event	10/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Following completion of laboratory analysis, this event will be further updated.
Event or Problem Description
It was reported that the patient with third degree atrioventricular (av) block was implanted with this device.During a post implant follow-up, the patient reported discomfort, at which time an electrogram review would illustrate return of the pre implanted, av block the physician elected to surgically intervene so as to further test the system, to include associated lead testing.All lead parameters were favorable however reconnecting to the device would confirm the previous observations and for this reason,the physician elected to remove and replace this device.No lead changes were required and the explanted device was later returned for laboratory analysis.No other resulting adverse effects were reported and the procedure was completed with the patient reported as stable.
Event or Problem Description
It was reported that the patient with third degree atrioventricular (av) block was implanted with this device.During a post implant follow-up, the patient reported discomfort, at which time an electrogram review would illustrate return of the pre implanted, av block the physician elected to surgically intervene so as to further test the system, to include associated lead testing.All lead parameters were favorable however reconnecting to the device would confirm the previous observations and for this reason, the physician elected to remove and replace this device.No lead changes were required and the explanted device was later returned for laboratory analysis.No other resulting adverse effects were reported and the procedure was completed with the patient reported as stable.
Additional Manufacturer Narrative
The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.The set screws were found to move normally and completely in both clockwise and counter clockwise directions, with no functional irregularities found.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.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.

• 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: 11218836
• Report Number: 2124215-2020-28819
• Device Sequence Number: 2946864
• 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: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2021

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: 01/13/2022
• Device Model Number: S702
• Device Catalogue Number: S702
• Device Lot Number: 708001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2020
• Initial Date Received by Manufacturer: 10/12/2020
• Supplement Date Received by Manufacturer: 05/06/2021
• Initial Report FDA Received Date: 01/22/2021
• Supplement Report FDA Received Date: 07/05/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening