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

Model Number	S401
Medical Device Problem Codes	Premature Discharge of Battery (1057); Interrogation Problem (4017)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that battery status indicators were different than expected based on information provided to boston scientific.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.
Event or Problem Description
It was reported that this pacemaker had varying longevity estimates.In (b)(6) 2014 there was 4.5 years remaining.In (b)(6) 2016 it was 3 years but in (b)(6) 2020 there is more than 5 years and battery status is beginning of life (bol).Boston scientific technical services (ts) noted that due to lack of therapy needs this is not unexpected.Additional information received indicates that there has been difficulty interrogating this device.In the past the device could not be interrogated while the patient was laying down but could while they were seated.More recently the device could not be interrogated despite trying two different programmers, two different power cables and three different wands.After an hour of trying to interrogate the physician stopped trying.The device is not needed by the patient as they have been in permanent atrial fibrillation (af) for years.

• 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: 10237466
• Report Number: 2124215-2020-12484
• Device Sequence Number: 536641
• Product Code: LWP
• UDI-Device Identifier: 00802526484438
• UDI-Public: 00802526484438
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: N970003/S096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/27/2011
• Device Model Number: S401
• Device Catalogue Number: S401
• Device Lot Number: 568554
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2020
• Initial Report FDA Received Date: 07/06/2020
• Patient Sequence Number: 1