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

Model Number S606

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Use of Device Problem (1670)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191); Insufficient Information (4580)

Event Date 07/24/2020

Event Type  Injury  

Manufacturer Narrative

No additional information is available.If additional information becomes available the report will be updated at that time.

Event Description

It was reported that the pacemaker was showing a message it was in magnet mode when there was no magnet present.Boston scientific technical services (ts) was consulted and walked the field representative through attempting to reset the magnet operating from asynchronous to off but it would not allow any programming.Electrogram (egms) were also not available.Ts noted that the pacemaker appears to be not performing as intended and recommended replacement.At this time the pacemaker remains in service and no adverse patient effects were reported.

Manufacturer Narrative

Patient code (b)(6) captures the reportable event of surgery.At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.

Event Description

Additional information as received that prior to the explant procedure, the pacemaker was interrogated and showed normal device function with no magnet mode noted.The battery status showed two years remaining.The field representative consulted boston scientific technical services (ts) who noted that since it was confirmed at the last check that the device was stuck in a magnet mode and the issue could not be resolved with troubleshooting, they could not guarantee that this behavior would not happen again in this device.Ts recommended device replacement.Subsequently the pacemaker was explanted and replaced.No additional adverse patient effects were reported.

Event Description

It was reported that the pacemaker was showing a message it was in magnet mode when there was no magnet present.Boston scientific technical services (ts) was consulted and walked the field representative through attempting to reset the magnet operating from asynchronous to off but it would not allow any programming.Electrogram (egms) were also not available.Ts noted that the pacemaker appears to be not performing as intended and recommended replacement.At this time the pacemaker remains in service and no adverse patient effects were reported.Additional information as received that prior to the explant procedure, the pacemaker was interrogated and showed normal device function with no magnet mode noted.The battery status showed two years remaining.The field representative consulted boston scientific technical services (ts) who noted that since it was confirmed at the last check that the device was stuck in a magnet mode and the issue could not be resolved with troubleshooting, they could not guarantee that this behavior would not happen again in this device.Ts recommended device replacement.Subsequently the pacemaker was explanted and replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

Patient code 3191 captures the reportable event of surgery.At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.The device was then exposed to simulated heart load conditions, and the pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Magnet function was tested 15 times.With a magnet applied the pacing rate went to 100 paces per minute with the magnet removed the pacing rate returned to the lower rate limit- normal magnet switch operation was noted during analysis.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.

• 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: 10619729
• MDR Text Key: 209600274
• Report Number: 2124215-2020-16753
• 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,Followup
• Report Date: 06/25/2021

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: 06/28/2012
• Device Model Number: S606
• Device Catalogue Number: S606
• Device Lot Number: 138895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Initial Date Manufacturer Received: 07/24/2020
• Initial Date FDA Received: 10/02/2020
• Supplement Dates Manufacturer Received: 08/28/2020; 04/08/2021
• Supplement Dates FDA Received: 10/19/2020; 06/25/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR