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

Model Number K083

Device Problems Over-Sensing (1438); Pacing Problem (1439); Use of Device Problem (1670)

Patient Problem Palpitations (2467)

Event Date 10/05/2017

Event Type  Injury  

Manufacturer Narrative

The device remains in service.Additional investigation is being performed to determine whether the device was being reused, and why it was implanted after the ubd.The patient's next follow-up was scheduled for the next month, where the boston scientific field representative will request to save a copy of the device memory for engineering evaluation.This report will be updated when additional information is received.

Event Description

Boston scientific received information that the patient implanted with this pacemaker had presented to the hospital due to palpitations.A holter monitor study found a one second pause in pacing.The patient was hospitalized and the field representative interrogated the device.Lead measurements were all normal, but one episode was stored showing two beats of inhibited pacing due to farfield sensing.Sensitivity was adjusted to resolve the oversensing.The field representative observed a mismatch of patient data and implant date in the device.The patient told the representative what date the device was implanted and it was then considered that this device had likely been implanted in another patient previously.A review of the device tracking system showed this device had a use before date (ubd) of (b)(6) 2017 and the patient reported the device was implanted on (b)(6) 2017.No additional adverse patient effects were reported.

Manufacturer Narrative

The device remains in service with no further complications reported.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

Boston scientific received information about this case.The patient has not presented for a new follow up.The hospital planned to contact the boston scientific representative when the patient was available for a device check.No adverse patient effects were reported.

• Brand Name: INGENIO
• Type of Device: IMPLANTABLE PULSE 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: 7190520
• MDR Text Key: 97356820
• Report Number: 2124215-2017-19396
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• 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
• Report Date: 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/02/2017
• Device Model Number: K083
• Other Device ID Number: ADVANTIO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 02/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 54 YR