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

Model Number L301

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439); Inaccurate Synchronization (1609); Under-Sensing (1661)

Patient Problems Atrial Fibrillation (1729); Ventricular Fibrillation (2130)

Event Date 03/24/2022

Event Type  Injury  

Manufacturer Narrative

The local area field representative was contacted for additional information.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a pacemaker to cardiac resynchronization therapy pacemaker (crt-p) upgrade procedure, the patient went into a combination of atrial fibrillation (af) and ventricular fibrillation (vf) while the new left ventricular (lv) lead was being placed.The pocket was opened using electrocautery.Review of strips showed a significant amount of cautery noise, and asynchronous pacing is occasionally seen.There is one beat of ap-noise that occurs at the same time as a ventricular beat, which blanks the device from seeing the intrinsic beat.The av delay times out, and paces in the ventricle.Immediately after, af and vf begin.It is unclear whether the af and vf were triggered by r on t or if the af may have been triggered by residual energy on the leads due to electrocautery.The strip later shows successful external cardioversion to a-v sequential pacing.This lv lead was removed prior to pocket closure and a different lv lead model was successfully implanted.The pacemaker was explanted, and the upgrade procedure was completed.No additional adverse patient effects were reported.

Event Description

It was reported that during a pacemaker to cardiac resynchronization therapy pacemaker (crt-p) upgrade procedure, the patient went into a combination of atrial fibrillation (af) and ventricular fibrillation (vf) while the new left ventricular (lv) lead was being placed.The pocket was opened using electrocautery.Review of strips showed a significant amount of cautery noise, and asynchronous pacing is occasionally seen.There is one beat of ap-noise that occurs at the same time as a ventricular beat, which blanks the device from seeing the intrinsic beat.The av delay times out, and paces in the ventricle.Immediately after, af and vf begin.It is unclear whether the af and vf were triggered by r on t or if the af may have been triggered by residual energy on the leads due to electrocautery.The strip later shows successful external cardioversion to a-v sequential pacing.This lv lead was removed prior to pocket closure and a different lv lead model was successfully implanted.The pacemaker was explanted, and the upgrade procedure was completed.No additional adverse patient effects were reported.

Manufacturer Narrative

The local area field representative was contacted for additional information.If information is provided in the future, a supplemental report will be issued.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.Dimensional analysis of the header 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 DR
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 14181266
• MDR Text Key: 289858773
• Report Number: 2124215-2022-12348
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526559174
• UDI-Public: 00802526559174
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N970003/S167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/23/2017
• Device Model Number: L301
• Device Catalogue Number: L301
• Device Lot Number: 725236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 78 YR
• Patient Sex: Male