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

Model Number J177

Device Problems Premature Discharge of Battery (1057); Battery Problem (2885); Data Problem (3196)

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

Event Date 11/23/2022

Event Type  Injury  

Event Description

It was reported that this pacemaker showed a decrease in the remining longevity, from five years remining at the previous follow up six months ago to three years remining currently.Premature battery depletion was suspected.It was also noted that the device showed 100% atrial fibrillation (af) and 1553.4 days in af, but this was not accurate for the patient's condition.Device data was submitted to technical services for review.Engineering review confirmed the battery appeared to be depleting faster than expected and device replacement was recommended for within 90 days.Technical services also discussed the erroneous af data was due to a single bit error, which caused the arrhythmia duration value to be corrupted.This did not affect device function.It was noted the physician planned to see the patient again in 90 days to discuss replacement.No adverse patient effects were reported.The device remains implanted and in service.

Manufacturer Narrative

This report will be updated when additional information is received.

Manufacturer Narrative

This report will be updated when additional information is received.If pertinent information is provided in the future, a supplemental report will be submitted.

Event Description

It was reported that this pacemaker showed a decrease in the remining longevity, from five years remining at the previous follow up six months ago to three years remining currently.Premature battery depletion was suspected.It was also noted that the device showed 100% atrial fibrillation (af) and 1553.4 days in af, but this was not accurate for the patient's condition.Device data was submitted to technical services for review.Engineering review confirmed the battery appeared to be depleting faster than expected and device replacement was recommended for within 90 days.Technical services also discussed the erroneous af data was due to a single bit error, which caused the arrhythmia duration value to be corrupted.This did not affect device function.It was noted the physician planned to see the patient again in 90 days to discuss replacement.Additional information was received.The physician decided to continue monitoring this device and the next follow up was planned for 30-august-2023.No adverse patient effects were reported.The device remains implanted and in service.

Manufacturer Narrative

This report will be updated when additional information is received.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 this pacemaker showed a decrease in the remaining longevity, from five years remaining at the previous follow up six months ago to three years remaining currently.Premature battery depletion was suspected.It was also noted that the device showed 100% atrial fibrillation (af) and 1553.4 days in af, but this was not accurate for the patient's condition.Device data was submitted to technical services for review.Engineering review confirmed the battery appeared to be depleting faster than expected and device replacement was recommended for within 90 days.Technical services also discussed the erroneous af data was due to a single bit error, which caused the arrhythmia duration value to be corrupted.This did not affect device function.It was noted the physician planned to see the patient again in 90 days to discuss replacement.Additional information was received.The physician decided to continue monitoring this device and the next follow up was planned for (b)(6) 2023.No adverse patient effects were reported.The device remains implanted and in service.It was later reported that the device was explanted and replaced on (b)(6) 2023.No additional adverse patient effects were reported.The explanted device was returned for analysis.

Manufacturer Narrative

This report will be updated when additional information is received.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.Upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.Longevity calculations were performed, and an increased rate of power consumption was confirmed.Analysis confirmed this device appeared to be exhibiting behavior consistent with a high current condition associated with the pacemaker's low voltage capacitors.This high current condition depleted the devices battery faster than normal.Data analysis determined a single bit error in the device memory had caused the erroneous information in the atrial fibrillation counters; this is diagnostic data only and does not affect device operation.

Event Description

It was reported that this pacemaker showed a decrease in the remining longevity, from five years remining at the previous follow up six months ago to three years remining currently.Premature battery depletion was suspected.It was also noted that the device showed 100% atrial fibrillation (af) and 1553.4 days in af, but this was not accurate for the patient's condition.Device data was submitted to technical services for review.Engineering review confirmed the battery appeared to be depleting faster than expected and device replacement was recommended for within 90 days.Technical services also discussed the erroneous af data was due to a single bit error, which caused the arrhythmia duration value to be corrupted.This did not affect device function.It was noted the physician planned to see the patient again in 90 days to discuss replacement.Additional information was received.The physician decided to continue monitoring this device and the next follow up was planned for (b)(6) 2023.No adverse patient effects were reported.The device remains implanted and in service.It was later reported that the device was explanted and replaced on (b)(6) 2023.No additional adverse patient effects were reported.The explanted device was returned for analysis.

• Brand Name: INGENIO
• 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: 15990941
• MDR Text Key: 306244300
• Report Number: 2124215-2022-52994
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: HK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/17/2024

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: 12/11/2016
• Device Model Number: J177
• Device Catalogue Number: J177
• Device Lot Number: 483988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2022
• Initial Date FDA Received: 12/15/2022
• Supplement Dates Manufacturer Received: 03/28/2023; 09/15/2023; 12/27/2023
• Supplement Dates FDA Received: 04/17/2023; 10/10/2023; 01/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 84 YR