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

Model Number L300

Device Problems Failure to Capture (1081); Pacing Problem (1439); Defective Device (2588)

Patient Problems Syncope (1610); Head Injury (1879); Seizures (2063); No Known Impact Or Consequence To Patient (2692)

Event Date 06/07/2019

Event Type  Injury  

Manufacturer Narrative

The product has been received for analysis.This investigation will be updated should pertinent information be provided.

Event Description

It was reported that this device was explanted due to product performance issue.This device was successfully replaced.No additional adverse patient effects.

Manufacturer Narrative

The product has been received for analysis.This investigation will be updated should pertinent information be provided.

Event Description

Additional information was received stating this patient presented to the emergency room after experiencing a syncopal event and hitting his head.The patient reported there have been five events of seizures.Device evaluation identified periods of a slow heart rate and failure to capture.There were no stored events showing noise or evidence of an issue with the associated lead.A revision procedure was performed and the system was removed from service.No additional adverse patient effects were reported.

Event Description

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

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the device was performed.A visual inspection of the device header and case noted no anomalies.Pin gauge testing, designed to verify proper port dimensions, was completed.Each port measured as expected.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.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.

• Brand Name: ACCOLADE SR
• 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: 8794304
• MDR Text Key: 151160017
• Report Number: 2124215-2019-13809
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526559150
• UDI-Public: 00802526559150
• Combination Product (y/n): N
• PMA/PMN Number: N970003/S167
• 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: 09/30/2019

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: 11/18/2017
• Device Model Number: L300
• Device Catalogue Number: L300
• Device Lot Number: 708601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Initial Date Manufacturer Received: 06/07/2019
• Initial Date FDA Received: 07/16/2019
• Supplement Dates Manufacturer Received: 06/07/2019; 09/24/2019
• Supplement Dates FDA Received: 08/07/2019; 09/30/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 85 YR