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

Model Number G148

Device Problem High impedance (1291)

Patient Problems Atrial Fibrillation (1729); Pain (1994)

Event Date 08/20/2018

Event Type  malfunction  

Manufacturer Narrative

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 that the cardiac resynchronization therapy defibrillator (crt-d) and non-boston scientific right atrial (ra) lead exhibited high out-of-range pace impedance of greater than 3,000 ohms.The patient with this system was noted to have chronic atrial fibrillation (af).Boston scientific technical services (ts) recommended further testing to evaluate the ra lead.The patient reported an aching feeling while doing arm movements.The patient also reported having sharp pains down the same left arm two weeks after their bypass surgery during which the ra had been cannulated.Ts suspected the arm pain and aching feeling were not related to the high impedance on the ra lead.Further testing was done and intermittent fluctuating impedances were noted on the ra both during isometrics and at rest.Ra sensing was turned off and the crt-d was programmed to pace and sense in the ventricle only.This product remains in service.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: 7983640
• MDR Text Key: 124359427
• Report Number: 2124215-2018-18964
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534591
• UDI-Public: (01)00802526534591(17)20200326
• 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: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/26/2020
• 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: 08/21/2018
• Initial Date FDA Received: 10/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2018
• 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: 0296; 1488TC; 4592; 4674; 5370; G148; N140; S606
• Patient Age: 73 YR