MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACCOLADE EL DR; PACEMAKER

Model Number L321

Device Problems Failure to Capture (1081); Pacing Problem (1439); Use of Device Problem (1670)

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

Event Date 08/07/2022

Event Type  Injury  

Event Description

It was reported that this pacemaker system exhibited pacing inhibition as well as loss of capture (loc) with no asystole.Also reported that this device did not perform a safety switch.The patient was evaluated in the emergency department and the device was reprogrammed to a unipolar configuration.Subsequently, the device was explanted and replaced.The right ventricular (rv) lead was capped and surgically abandoned.No additional adverse patient effects were reported.

Manufacturer Narrative

The returned device was inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.Pacing and sensing functions were tested and the device was verified to operate as expected.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.

Event Description

It was reported that this pacemaker system exhibited pacing inhibition as well as loss of capture (loc) with no asystole.Also reported that this device did not perform a safety switch.The patient was evaluated in the emergency department and the device was reprogrammed to a unipolar configuration.Subsequently, the device was explanted and replaced.The right ventricular (rv) lead was capped and surgically abandoned.No additional adverse patient effects were reported.

• Brand Name: ACCOLADE EL DR
• Type of Device: PACEMAKER
• 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: 15237072
• MDR Text Key: 298006910
• Report Number: 2124215-2022-30878
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526559242
• UDI-Public: 00802526559242
• 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
• Type of Report: Initial,Followup
• Report Date: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/30/2017
• Device Model Number: L321
• Device Catalogue Number: L321
• Device Lot Number: 700654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male