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

Model Number L301

Device Problems Pocket Stimulation (1463); Incorrect, Inadequate or Imprecise Result or Readings (1535); Inappropriate or Unexpected Reset (2959); Interrogation Problem (4017)

Patient Problem Device Overstimulation of Tissue (1991)

Event Date 03/28/2023

Event Type  Injury  

Event Description

It was reported that the patient implanted with this pacemaker had presented to the emergency room (er) with pocket/muscle stimulation.Device interrogation was attempted and unsuccessful.It was determined that this pacemaker had entered safety mode.Subsequently, this pacemaker was explanted and replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

If pertinent information is provided in the future, a supplemental report will be submitted.

Manufacturer Narrative

If pertinent information is provided in the future, a supplemental report will be submitted.The product has been received for analysis.This report will be updated upon completion of analysis.

Event Description

It was reported that the patient implanted with this pacemaker had presented to the emergency room (er) with pocket/muscle stimulation.Device interrogation was attempted and unsuccessful.It was determined that this pacemaker had entered safety mode.Subsequently, this pacemaker was explanted and replaced.No additional adverse patient effects were reported.This pacemaker was returned for analysis.

Event Description

It was reported that the patient implanted with this pacemaker had presented to the emergency room (er) with pocket/muscle stimulation.Device interrogation was attempted and unsuccessful.It was determined that this pacemaker had entered safety mode.Subsequently, this pacemaker was explanted and replaced.No additional adverse patient effects were reported.This pacemaker was returned for analysis.

Manufacturer Narrative

If pertinent information is provided in the future, a supplemental report will be submitted.-- correction to section h: updated to reflect product return and pending analysis.The product has been received for analysis.This report will be updated upon completion of analysis.-- upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Interrogation of the device confirmed it was operating in safety mode, 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.

• 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: 16716220
• MDR Text Key: 313059592
• Report Number: 2124215-2023-16912
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date: 08/18/2023

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: 11/04/2017
• Device Model Number: L301
• Device Catalogue Number: L301
• Device Lot Number: 723372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2023
• Initial Date Manufacturer Received: 04/11/2023
• Initial Date FDA Received: 04/11/2023
• Supplement Dates Manufacturer Received: 04/11/2023; 08/10/2023
• Supplement Dates FDA Received: 04/11/2023; 08/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2015
• 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: 75 YR
• Patient Sex: Male