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

Model Number L321

Device Problems Failure to Capture (1081); Incorrect, Inadequate or Imprecise Result or Readings (1535); Inappropriate or Unexpected Reset (2959); High Capture Threshold (3266)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/03/2024

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 the patient implanted with this pacemaker system was hospitalized due to loss of pacing and worsening heart failure.Upon interrogation, it was determined that the pacemaker had entered safety mode and switched to unipolar mode.It was suspected that there was loss of capture (loc) at 5v in unipolar, rather than unipolar oversensing with pacing inhibition, as paced signals were observed.Subsequently, this pacemaker was explanted and replaced with another manufacturer's device.Upon connecting the chronic lead with the new device, a threshold measurement of 4v was observed in bipolar.No additional adverse patient effects were reported.This pacemaker has been returned for analysis.

Manufacturer Narrative

The product has been received for analysis.This report will be updated upon completion of analysis.Correction to b5: edited to reflect new output of 4v, not threshold measurement.Correction to h6: removed high capture threshold code, as there was no allegation of high thresholds.

Event Description

It was reported that the patient implanted with this pacemaker system was hospitalized due to loss of pacing and worsening heart failure.Upon interrogation, it was determined that the pacemaker had entered safety mode and switched to unipolar mode.It was suspected that there was loss of capture (loc) at 5v in unipolar, rather than unipolar oversensing with pacing inhibition, as paced signals were observed.Subsequently, this pacemaker was explanted and replaced with another manufacturer's device.Upon connecting the chronic lead with the new device, output was set to 4v in bipolar.No additional adverse patient effects were reported.This pacemaker has been returned for analysis.

Manufacturer Narrative

The product has been received for analysis.This report will be updated upon completion of analysis.Correction to b5: edited to reflect new output of 4v, not threshold measurement.Correction to h6: removed high capture threshold code, as there was no allegation of high thresholds.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, determined it had undergone resets, and that bradycardia 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.

Event Description

It was reported that the patient implanted with this pacemaker system was hospitalized due to loss of pacing and worsening heart failure.Upon interrogation, it was determined that the pacemaker had entered safety mode and switched to unipolar mode.It was suspected that there was loss of capture (loc) at 5v in unipolar, rather than unipolar oversensing with pacing inhibition, as paced signals were observed.Subsequently, this pacemaker was explanted and replaced with another manufacturer's device.Upon connecting the chronic lead with the new device, output was set to 4v in bipolar.No additional adverse patient effects were reported.This pacemaker has been returned for analysis.

• Brand Name: ACCOLADE EL 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: 18567978
• MDR Text Key: 333536064
• Report Number: 2124215-2024-03538
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N970003/S167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/10/2018
• Device Model Number: L321
• Device Catalogue Number: L321
• Device Lot Number: 716497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2016
• 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