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

Model Number G148

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

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

Event Date 10/01/2017

Event Type  Injury  

Manufacturer Narrative

No additional information is available.If additional information becomes available the report will be updated at that time.

Event Description

Boston scientific received information that the cardiac resynchronization therapy defibrillator (crt-d) and another manufacturer's right atrial (ra) lead exhibited oversensing of the minute ventilation feature.Abrupt changes in the ra lead impedance measurements were also observed.It was noted that several times a week the impedance measurement would go from 600 ohms to greater than 3000 ohms and then back down.Noise that was not being sensed and not from the minute ventilation signal was also seen.The patient was hospitalized for a revision procedure.Prior to the procedure, boston scientific technical services (ts) was consulted and reviewed date from the remote home monitoring system.Ts found that the abrupt changes in impedance started eight months after implant.Ts discussed checking connection between the lead and device along with observing for an lead or device anomaly.It is unknown if the procedure took place.At this time the crt-d and ra lead remain in service an no adverse patient effects were reported.

• Brand Name: INOGEN
• 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: 7730654
• MDR Text Key: 115350300
• Report Number: 2124215-2018-13810
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534591
• UDI-Public: 00802526534591
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/15/2018

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: 06/10/2018
• Device Model Number: G148
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 05/15/2018
• Initial Date FDA Received: 07/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2016
• 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: 0282; 4574; 4671; G148
• Patient Outcome(s): Hospitalization
• Patient Age: 73 YR