MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACCOLADE DR; PACEMAKERS

Model Number L301

Device Problems Signal Artifact/Noise (1036); Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535); Inappropriate or Unexpected Reset (2959)

Patient Problem Syncope/Fainting (4411)

Event Date 02/20/2024

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 device check prior to a scheduled atrial fibrillation (af) ablation, device interrogation revealed that this pacemaker system had entered safety mode.The physician decided to proceed with the ablation, and follow up with device replacement.Safety mode settings were reviewed (vvi 72), and technical services (ts) discussed loss atrial support while in safety mode for a patient that was 100% right atrial (ra) paced and 68% right ventricular (rv) paced.The patient presented to the emergency room (er) two days later with four episodes of syncope.Review of remote monitoring data revealed crosstalk signals on the rv channel that were possibly attributed to high septal rv lead placement.The crosstalk signals were not sensed and were appropriately blanked.The following day, the pacemaker was explanted and replaced.It was noted that a temporary pacing wire was used during the procedure.No additional adverse patient effects were reported.The pacemaker was returned for analysis.

Manufacturer Narrative

Correction to h6: impact code f2301 added to reflect the use of a temporary pacing wire during the procedure.The product has been received for analysis.This report will be updated upon completion of analysis.

Event Description

It was reported that during a device check prior to a scheduled atrial fibrillation (af) ablation, device interrogation revealed that this pacemaker system had entered safety mode.The physician decided to proceed with the ablation, and follow up with device replacement.Safety mode settings were reviewed (vvi 72), and technical services (ts) discussed loss atrial support while in safety mode for a patient that was 100% right atrial (ra) paced and 68% right ventricular (rv) paced.The patient presented to the emergency room (er) two days later with four episodes of syncope.Review of remote monitoring data revealed crosstalk signals on the rv channel that were possibly attributed to high septal rv lead placement.The crosstalk signals were not sensed and were appropriately blanked.The following day, the pacemaker was explanted and replaced.It was noted that a temporary pacing wire was used during the procedure.No additional adverse patient effects were reported.The pacemaker was returned for analysis.

Event Description

It was reported that during a device check prior to a scheduled atrial fibrillation (af) ablation, device interrogation revealed that this pacemaker system had entered safety mode.The physician decided to proceed with the ablation, and follow up with device replacement.Safety mode settings were reviewed (vvi 72), and technical services (ts) discussed loss atrial support while in safety mode for a patient that was 100% right atrial (ra) paced and 68% right ventricular (rv) paced.The patient presented to the emergency room (er) two days later with four episodes of syncope.Review of remote monitoring data revealed crosstalk signals on the rv channel that were possibly attributed to high septal rv lead placement.The crosstalk signals were not sensed and were appropriately blanked.The following day, the pacemaker was explanted and replaced.It was noted that a temporary pacing wire was used during the procedure.No additional adverse patient effects were reported.The pacemaker was returned for analysis.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Device telemetry data confirmed it was operating in safety mode and that critical therapy remained available.Engineers determined that this device was demonstrating behavior consistent with a high internal cell impedance within the battery.The high internal impedance put this device at risk of experiencing transient voltage decreases (and associated resets) during periods of high-power consumption.When battery voltage drops below a minimum threshold, a system reset is performed.If three system resets occur within a 48-hour period, the device is designed to immediately enter safety mode operation to maintain back-up pacing with pre-defined, non-programmable settings.Correction to h6: impact code f2301 added to reflect the use of a temporary pacing wire during the procedure.The product has been received for analysis.This report will be updated upon completion of analysis.

• Brand Name: ACCOLADE DR
• Type of Device: PACEMAKERS
• 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: 18823059
• MDR Text Key: 336738832
• Report Number: 2124215-2024-12718
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 05/21/2024

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: 11/10/2017
• Device Model Number: L301
• Device Catalogue Number: L301
• Device Lot Number: 724085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 03/01/2024
• Supplement Dates Manufacturer Received: 02/20/2024; 04/30/2024
• Supplement Dates FDA Received: 03/04/2024; 05/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2015
• 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; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Female