MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALTRUA 50; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number S501

Device Problem Premature Discharge of Battery (1057)

Patient Problems Ventricular Tachycardia (2132); No Code Available (3191)

Event Date 09/29/2020

Event Type  Injury  

Manufacturer Narrative

The device is expected to be returned for analysis.This report will be updated upon the completion of the investigation.(b)(4).

Event Description

It was reported that premature battery depletion was suspected.The previous device interrogation showed one year of battery remaining, and a magnet rate of 90 bpm.The patient was recently admitted to the hospital, and another device interrogation was performed, which showed the battery status was at eol (end of life).The patient is pacemaker dependent, and had several vt (ventricular tachycardia) episodes with no evidence of pauses longer than 3 seconds.The device was explanted and replaced the following day.No additional adverse patient effects were reported.

Event Description

It was reported that premature battery depletion was suspected.The previous device interrogation showed one year of battery remaining, and a magnet rate of 90 bpm.The patient was recently admitted to the hospital, and another device interrogation was performed, which showed the battery status was at eol (end of life).The patient is pacemaker dependent, and had several vt (ventricular tachycardia) episodes with no evidence of pauses longer than 3 seconds.The device was explanted and replaced the following day.No additional adverse patient effects were reported.

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, it was reported from the field that 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.Of note, the estimated remaining battery longevity of this pacemaker was designed to be calculated (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 patient code 3191 captures the reportable event of surgery.

• Brand Name: ALTRUA 50
• 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: 10642727
• MDR Text Key: 210218131
• Report Number: 2124215-2020-19881
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/17/2011
• Device Model Number: S501
• Device Catalogue Number: S501
• Device Lot Number: 572030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Date Manufacturer Received: 11/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention