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

Model Number L311

Device Problems Premature Discharge of Battery (1057); Failure to Capture (1081); Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535); Under-Sensing (1661); Use of Device Problem (1670); Inappropriate or Unexpected Reset (2959); Interrogation Problem (4017)

Patient Problems Dyspnea (1816); Pain (1994); Burning Sensation (2146)

Event Date 03/30/2022

Event Type  Injury  

Event Description

It was reported that the patient presented to the clinic with complaint of a burning sensation, pain over the pacemaker and shortness of breath (sob).The physician noted that the skin appeared normal, however, was tender to the touch.The patient noted having lithotripsy within the past month.Review of a surface electrogram (egm) noted no pacing spikes or paced complexes.An attempt was made to interrogate the device with three different programmers, however, an interrogation was unsuccessful.Additionally, a magnet response was unable to be obtained.The patient presented to the hospital for a device replacement procedure three weeks later.Prior to the procedure, the device was able to be interrogated with a programmer and was found to have reverted to safety mode.The device was explanted and replaced.No additional adverse patient effects were reported.At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.

Event Description

It was reported that the patient presented to the clinic with complaint of a burning sensation, pain over the pacemaker and shortness of breath (sob).The physician noted that the skin appeared normal, however, was tender to the touch.The patient noted having lithotripsy within the past month.Review of a surface electrogram (egm) noted no pacing spikes or paced complexes.An attempt was made to interrogate the device with three different programmers, however, an interrogation was unsuccessful.Additionally, a magnet response was unable to be obtained.The patient presented to the hospital for a device replacement procedure three weeks later.Prior to the procedure, the device was able to be interrogated with a programmer and was found to have reverted to safety mode.The device was explanted and replaced.No additional adverse patient effects were reported.At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.It was reported that an error message was observed during the pre-procedure interrogation, the device exhibited pacing inhibition, undersensing, there was concern of loss of capture (loc) and the device battery was also suspected to have depleted prematurely.The product has been received for analysis.

Manufacturer Narrative

This device was thoroughly inspected and analyzed upon receipt at our quality assurance laboratory.The device had no telemetry and could not be interrogated.The device case was removed to facilitate inspection of the internal components and further testing.The battery was noted to be slightly swollen; it was removed from the device and replaced with an external power source.The current drain was measured and found to be normal.Detailed analysis of the battery identified an internal short, which was caused by a tear in the cathode insulating tube.The short caused an increase in power consumption, which resulted in the slightly swollen battery, and the clinically-observed reversion to safety mode operation.

Event Description

It was reported that the patient presented to the clinic with complaint of a burning sensation, pain over the pacemaker and shortness of breath (sob).The physician noted that the skin appeared normal, however, was tender to the touch.The patient noted having lithotripsy within the past month.Review of a surface electrogram (egm) noted no pacing spikes or paced complexes.An attempt was made to interrogate the device with three different programmers, however, an interrogation was unsuccessful.Additionally, a magnet response was unable to be obtained.The patient presented to the hospital for a device replacement procedure three weeks later.Prior to the procedure, the device was able to be interrogated with a programmer and was found to have reverted to safety mode.The device was explanted and replaced.No additional adverse patient effects were reported.At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.It was reported that an error message was observed during the pre-procedure interrogation, the device exhibited pacing inhibition, undersensing, there was concern of loss of capture (loc) and the device battery was also suspected to have depleted prematurely.The product has been received for analysis.

• Brand Name: ACCOLADE MRI 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: 14164822
• MDR Text Key: 289723868
• Report Number: 2124215-2022-12321
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526559228
• UDI-Public: 00802526559228
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150012/S000
• 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,Followup
• Report Date: 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/18/2022
• Device Model Number: L311
• Device Catalogue Number: L311
• Device Lot Number: 525041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2020
• 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