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

Model Number J177

Device Problems Premature Discharge of Battery (1057); Incorrect, Inadequate or Imprecise Result or Readings (1535); Battery Problem (2885); Inappropriate or Unexpected Reset (2959)

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

Event Date 02/14/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the battery of this pacemaker was suspected to be depleting prematurely; this pacemaker entered safety mode while longevity estimates indicated the battery had 3.5 years remaining.It was noted that the patient was pacer dependent.This pacemaker remains in service, however device replacement was scheduled for (b)(6) 2023.No adverse patient effects were reported.

Manufacturer Narrative

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

Event Description

It was reported that the battery of this pacemaker was suspected to be depleting prematurely; this pacemaker entered safety mode while longevity estimates indicated the battery had 3.5 years remaining.It was noted that the patient was pacer dependent.This pacemaker remains in service, however device replacement was scheduled for (b)(6), 2023.No adverse patient effects were reported.Additional information received reported that device changeout was completed as scheduled.No additional adverse patient effects were reported.This device will not be return 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: 16401878
• MDR Text Key: 309875939
• Report Number: 2124215-2023-07512
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 03/25/2023

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: 08/18/2016
• Device Model Number: J177
• Device Catalogue Number: J177
• Device Lot Number: 105932
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2023
• Initial Date FDA Received: 02/20/2023
• Supplement Dates Manufacturer Received: 03/06/2023
• Supplement Dates FDA Received: 03/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2014
• 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: 80 YR
• Patient Sex: Male