MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND INGENIO; IMPLANTABLE CHF GENERATOR

Model Number V173

Device Problems Pacing Problem (1439); Device Displays Incorrect Message (2591)

Patient Problem Bradycardia (1751)

Event Date 12/29/2017

Event Type  Injury  

Manufacturer Narrative

The hospital has retained the device and planned to send to boston scientific for analysis.If the product is returned, analysis will be performed and this report would be updated at that time.

Event Description

Boston scientific received information that the patient with this cardiac resynchronization therapy pacemaker (crt-p), resided in a nursing home and received remote interrogations from a third party.During a recent remote interrogation it was identified that pacing therapy was not being provided and the patient's heart rate was in the forties.The patient was sent to the hospital.Upon device interrogation an alert was present indicative of battery voltage too low for the projected remaining capacity.It was reported the battery had depleted past end of life (eol) and the device had reverted to storage mode.The device was explanted and successfully replaced.No additional adverse patient effects were reported.

• Brand Name: INGENIO
• Type of Device: IMPLANTABLE CHF GENERATOR
• Manufacturer (Section D): GUIDANT CRM CLONMEL IRELAND; guidant ireland; clonmel, tipperary ireland
• Manufacturer (Section G): GUIDANT CRM CLONMEL IRELAND; guidant ireland; clonmel, tipperary ireland
• Manufacturer Contact: tim degroot ; 4100 hamline ave. n; st. paul, MN ; 6515826168
• MDR Report Key: 7216330
• MDR Text Key: 98117442
• Report Number: 2124215-2018-01272
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/12/2015
• Device Model Number: V173
• Other Device ID Number: INVIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2013
• 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
• Treatment: 4457; 4470; 4592; V173
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 83 YR