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

Model Number L301

Device Problems Failure to Capture (1081); High impedance (1291); Over-Sensing (1438); Pacing Problem (1439)

Patient Problems Syncope (1610); No Code Available (3191); Syncope/Fainting (4411)

Event Date 11/29/2020

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.(b)(4).

Event Description

It was reported that this patient had experienced syncopal episodes and system evaluation was being performed.A review of the stored data identified the lead safety switch had been triggered due to a pacing impedance measurement greater than 2000 ohms on the right ventricular (rv) channel.No capture was observed in bipolar configuration; therefore, the lead was reprogrammed to unipolar configuration.A revision procedure was subsequently performed and the rv lead was removed from service and replaced.Additionally, it was reported that several years ago the associated atrial lead had been exhibiting out of range pacing impedance measurements.Fluoroscopy revealed a lead fracture.The lead was electrically abandoned at that time.No additional adverse patient effects were reported.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Investigation of the available information determined this device exhibited oversensing of noise generated by the minute ventilation (mv)/respiratory sensor that is related to a high impedance condition.This device was included in the minute ventilation sensor signal oversensing advisory population.

Event Description

This supplemental report is being filed to update the investigation conclusion code and additional manufacturing narrative.

• Brand Name: ACCOLADE DR
• 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: 11212962
• MDR Text Key: 228163868
• Report Number: 2124215-2021-01434
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526559174
• UDI-Public: 00802526559174
• 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,health
• Type of Report: Initial,Followup
• Report Date: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/12/2017
• Device Model Number: L301
• Device Catalogue Number: L301
• Device Lot Number: 708987
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/17/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 83 YR