MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALTRUA 40; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number	S403
Medical Device Problem Codes	Premature Discharge of Battery (1057); High Capture Threshold (3266)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/14/2018
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 updated at that time.
Event or Problem Description
It was reported that during routine follow-up this pacemaker was found to have triggered a replacement indicator.It was noted that the patient had near 100% right atrial (ra) lead pacing and approximately 40% right ventricular (rv) lead pacing since implant.Magnet rates corresponding to depletion level were found inconsistent in the months preceding a request by the physician for device data analysis due to suspected premature depletion.Engineering analysis found the device was operating near a depletion indicator boundary that may have explained the observed behavior.Information was later received indicating a revision procedure was performed at which time this device was explanted and replaced.No adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, detailed mechanical and electrical testing was performed on the device.The device battery status was end of life (eol).The device functioned normally throughout testing.Laboratory analysis determined that this device experienced normal battery depletion; however, the estimated longevity remaining value appeared to decrease more quickly than expected between routine follow-ups.Factors influencing the estimated longevity remaining calculation include pacing rate, amplitude, pulse-width and lead impedance.Any (even slight) changes in these factors will impact the battery consumption calculation and therefore the remaining longevity estimate.Please note that, despite the drop in estimated longevity remaining, the actual battery condition did not change significantly between follow-ups.In summary, it was determined that this device experienced normal battery depletion, but declared (eol) earlier than previously estimated.

• Brand Name: ALTRUA 40
• 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: 8271284
• Report Number: 2124215-2019-00799
• Device Sequence Number: 137864
• Product Code: LWP
• UDI-Device Identifier: 00802526484445
• UDI-Public: 802526484445
• 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: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2019

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: Lay User/Patient
• Device Expiration Date: 09/13/2014
• Device Model Number: S403
• Device Catalogue Number: S403
• Device Lot Number: 592006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2019
• Initial Date Received by Manufacturer: 09/14/2018
• Supplement Date Received by Manufacturer: 12/27/2019
• Initial Report FDA Received Date: 01/23/2019
• Supplement Report FDA Received Date: 12/29/2019
• 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; Required Intervention
• Patient Age: 78 YR