MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALTRUA 60; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number	S601
Medical Device Problem Codes	Failure to Capture (1081); High Capture Threshold (3266)
Health Effect - Clinical Code	Syncope (1610)
Date of Event	07/24/2020
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 during an in-office visit the patient with this device, while already sitting in a chair, exhibited a syncopal episode during automatic threshold testing.The patient incurred no injury or adverse effects due to the period of asystole.The field representative was contacted for additional information and reported no known programming changes and this had been the first episode of this nature.During threshold testing, the pacing capture was absent for several beats and auto capture feature was noted as off.Data was sent for a technical services (ts) review of performance.The ts review noted that prior to turing off auto capture (ac) the device was at.9v at 0.4 msec meaning ac threshold would have been 0.4v at 0.4msec.The programmer commanded test for automatic capture does 5 warm up paces plus 12 initialization paces at 3.5v without back up paces.After the warm up and initialization pulses at 3.5v, the tests adds 0.5v to threshold which was 0.4v to start its decrement every 3 pulses, that is not programmable.It was unknown if the strips sent for review were gathered during the test to know the output or if the site was actually performing a commanded threshold test verses a manual test.Aside from confirmation of this information, non-capture with greater than 2 second pause was noted.The physician elected to programmed the output to 2.5v, which was noted to be lower output than the warm up and initialization pulses would be.

• Brand Name: ALTRUA 60
• 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: 10708342
• Report Number: 2124215-2020-21189
• Device Sequence Number: 14486987
• Product Code: LWP
• UDI-Device Identifier: 00802526484469
• UDI-Public: 00802526484469
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: N970003/S096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/20/2020

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: 06/21/2014
• Device Model Number: S601
• Device Catalogue Number: S601
• Device Lot Number: 176632
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 10/20/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 82 YR