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

Model Number J172

Device Problem Premature Discharge of Battery (1057)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/15/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that this device exhibited premature battery depletion (pbd) behavior.The battery appeared to be depleting more quickly than expected.Device replacement was recommended.No adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.The product has been received for analysis.This report would be updated should further information be provided from the analysis.

Event Description

It was reported that this implantable pulse generator (pacemaker) exhibited premature battery depletion (pbd) behavior.The battery appeared to be depleting more quickly than expected.Device replacement was recommended.Eventually, this device was explanted, replaced and returned for analysis.No additional adverse patient effects were reported.

Event Description

It was reported that this implantable pulse generator (pacemaker) exhibited premature battery depletion (pbd) behavior.The battery appeared to be depleting more quickly than expected.Device replacement was recommended.Eventually, this device was explanted, replaced and returned for analysis.No additional adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.The product has been received for analysis.This report would be updated should further information be provided from the analysis.Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and 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 device's battery faster than normal.

• Brand Name: INGENIO
• Type of Device: IMPLANTABLE PULSE GENERATOR (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: 11104227
• MDR Text Key: 225103929
• Report Number: 2124215-2020-25178
• Device Sequence Number: 1
• Product Code: LWW
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/14/2016
• Device Model Number: J172
• Device Catalogue Number: J172
• Device Lot Number: 109895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male