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

Model Number V173

Device Problems Ambient Noise Problem (2877); Device Sensing Problem (2917)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/05/2018

Event Type  Injury  

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the device was performed.Visual inspection noted no irregularities.The device passed all electrical tests.Laboratory testing was unable to reproduce the reported clinical observations and detailed analysis did not reveal any abnormalities.

Event Description

Boston scientific received information that the right ventricular (rv) lead exhibited noise during a device check.The noise was reproducible with inspiration and isometric exercises.No oversensing noted.The device was reprogrammed; however, the sensitivity of the rv lead decreased and it was decided to explant this cardiac resynchronization therapy pacemaker (crt-p).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: 8034706
• MDR Text Key: 126004856
• Report Number: 2124215-2018-19301
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030005/S079
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/14/2015
• Device Model Number: V173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 07/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2013
• 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: 4136; 4543; 7642; V173
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 10743 DA