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

Model Number	S404
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Following explant, return and completion of laboratory analysis, this event will be further updated.
Event or Problem Description
It was reported that the battery of this implantable device was suspected to be depleting prematurely.This device has been scheduled for replacement and returned to boston scientific for analysis post explant, is expected.No resulting adverse patient effects were reported at this time.
Event or Problem Description
It was reported that the battery of this implantable device was suspected to be depleting prematurely.This device has been scheduled for replacement and return to boston scientific for analysis post explant, is expected.No resulting adverse patient effects were reported at this time.Subsequently, the unit was explanted and returned for analysis.
Additional Manufacturer Narrative
The pacemaker was analyzed and an engineering-level longevity prediction calculation was completed to assess the rate of battery depletion.Given the programmed parameters and other data stored within the memory of the device, the results of this calculation indicated that the actual rate of battery depletion fell within an acceptable range.Next, a series of diagnostic tests were conducted that verified the performance of pacing, sensing, and recording functions.Impedance testing was completed and all measurements were within normal limits.Having met the engineering longevity prediction, functionally passed all returned product testing, and with no further information to indicate a product performance issue, we have concluded that this device experienced normal battery depletion.

• 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: 9947374
• Report Number: 2124215-2020-06563
• Device Sequence Number: 17003006
• Product Code: LWP
• UDI-Device Identifier: 00802526484452
• UDI-Public: 00802526484452
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: N970003/S106
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2020

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: 09/15/2016
• Device Model Number: S404
• Device Catalogue Number: S404
• Device Lot Number: 601491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2020
• Initial Date Received by Manufacturer: 03/20/2020
• Supplement Date Received by Manufacturer: 04/14/2020
• Initial Report FDA Received Date: 04/09/2020
• Supplement Report FDA Received Date: 07/17/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening