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

Model Number S606

Device Problem Premature Discharge of Battery (1057)

Patient Problems Atrial Flutter (1730); Death (1802)

Event Date 04/23/2020

Event Type  Death  

Manufacturer Narrative

Following return and completion of laboratory analysis, this event will be further updated.

Event Description

It was reported that the patient with this pacemaker device passed away from unreported causes.The local field representative was contacted to assist with a post mortem interrogation, deactivation and return of the device for episode review and a longevity evaluation.It was stated the device had been implanted over ten years and had been programmed in dddr and later vvir modes, due to atrial flutter.The patient was reportedly 100 percent ventricular paced with a stable remaining battery life at 2 years.The patient was intended to be seen for another follow-up in (b)(6) of 2020 however the appointment cancelled due to covid concerns and the rescheduled (b)(6) follow-up was unattended by the patient.The post mortem interrogation confirmed the end of life (eol) battery status had been set in april 2020 with a magnet rate of 85 and vvi pacing at 50.The patient passed away in (b)(6) 2020.The physician has not correlated the patients death directly to the depleted battery but has requested a longevity review for performance indication.

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 changes in these factors will impact the battery consumption calculation and therefore the remaining longevity estimate.Please refer to the description for more information regarding the specific circumstances of this event.Please note this pacemakers battery was designed to estimate remaining longevity and trigger corresponding device replacement indicators based on the pacing capacitor charge time, which progressively increases as the battery depletes.These pacemakers were not designed with an ability to calculate remaining longevity for every possible current drain, which may cause replacement indicators to trigger earlier than what was previously estimated; however, it does not negatively impact the use, operation, safety, or performance of the device.

Event Description

It was reported that the patient with this pacemaker device passed away from unreported causes.The local field representative was contacted to assist with a post mortem interrogation, deactivation and return of the device for episode review and a longevity evaluation.It was stated the device had been implanted over ten years and had been programmed in dddr and later vvir modes, due to atrial flutter.The patient was reportedly 100 percent ventricular paced with a stable remaining battery life at 2 years.The patient was intended to be seen for another follow-up in (b)(6) 2020 however the appointment cancelled due to covid concerns and the rescheduled august follow-up was unattended by the patient.The post mortem interrogation confirmed the end of life (eol) battery status had been set in (b)(6) 2020 with a magnet rate of 85 and vvi pacing at 50.The patient passed away in (b)(6) 2020.The physician has not correlated the patients death directly to the depleted battery but has requested a longevity review for performance indication.

• Brand Name: ALTRUA 60
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 10705214
• MDR Text Key: 212103781
• Report Number: 2124215-2020-21214
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526484490
• UDI-Public: 00802526484490
• Combination Product (y/n): N
• PMA/PMN Number: N970003/S106
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/23/2020

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/16/2011
• Device Model Number: S606
• Device Catalogue Number: S606
• Device Lot Number: 120284
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/24/2020
• Initial Date FDA Received: 10/20/2020
• Supplement Dates Manufacturer Received: 10/30/2020
• Supplement Dates FDA Received: 11/23/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Death