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

Model Number S603

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/12/2019

Event Type  Injury  

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

It was reported that telemetry could not be established with this device and a magnet rate could not be obtained.The device was explanted and replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

Upon receipt in our post market quality assurance laboratory, a thorough evaluation of the device was performed.The device had no output and no telemetry.The device data was insufficient to obtain battery status and a memory download could not be performed.High powered visual inspection of the hybrid noted no irregularities and there was no foreign material noted inside the device case.In house analysis of the battery confirmed the current drain was within tolerance of the circuit.The battery was sent for outside analysis which confirmed there was no internal short within the battery.Laboratory analysis confirmed the telemetry issues were due to a depleted battery; however, the root cause of the depleted battery could not be determined.

Event Description

This supplemental report is being filed due to the completed evaluation of this product.

• 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: 9225405
• MDR Text Key: 163366553
• Report Number: 2124215-2019-22063
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526484483
• UDI-Public: 00802526484483
• Combination Product (y/n): N
• PMA/PMN Number: N970003/S096
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/27/2011
• Device Model Number: S603
• Device Catalogue Number: S603
• Device Lot Number: 147662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2019
• Date Manufacturer Received: 01/27/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 96 YR