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

Model Number V173

Device Problems High impedance (1291); Over-Sensing (1438); Pacing Problem (1439); Ambient Noise Problem (2877)

Patient Problems Syncope (1610); Dizziness (2194)

Event Date 05/22/2018

Event Type  Injury  

Manufacturer Narrative

The device remains in service at this time. If additional information is received, this report will be updated.

Event Description

Boston scientific received information that the patient with this cardiac resynchronization therapy pacemaker (crt-p) presented to the emergency room with dizzy spells. The device and a non-boston scientific right ventricular (rv) lead exhibited noise, oversensing, pacing inhibition of approximately two seconds, and impedance measurements of greater than 2000 ohms. It was questioned if the noise could have been due to minute ventilation (mv) oversensing, although it was noted that the noise did not look like mv signals. This feature was programmed off. Patient isometrics were performed which did not reproduce any noise. The patient had also experienced a syncopal event. There were no events stored in the device at the time of the syncope; however, it was noted that the events may have been overwritten. Programming options were discussed at that time. A lead fracture was suspected. A surgical revision was performed and the non-boston scientific rv lead was surgically abandoned and replaced. This device remains in service with the new lead. 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: 7755742
• MDR Text Key: 116204359
• Report Number: 2124215-2018-15017
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/14/2016
• Device Model Number: V173
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: No Information
• Date Manufacturer Received: 05/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 08/07/2018 Patient Sequence Number: 1

Treatment

4135; 4549; 5076; V173