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

Model Number G141

Device Problems Device Alarm System (1012); High impedance (1291); Capturing Problem (2891)

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

Event Date 05/12/2018

Event Type  Injury  

Manufacturer Narrative

A boston scientific technical services consultant documented and discussed the clinical observations with the caller who stated the device the checked a second time one week later and no additional out of range measurements were noted.No x-ray or additional testing was performed.The physician will continue to monitor the patient.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 this patient presented to the emergency room due to her device emitting tones.System evaluation identified a pacing impedance measurement greater than 2200 ohms.No adverse patient effects were reported.

Manufacturer Narrative

Additional information was received stating the device was still emitting tones and the rv pacing impedance was still out of range.Threshold measurements were also elevated.Fluoroscopy did not identify any lead issues and no set screw issues were observed during the revision procedure.The pace/sense portion of the rv lead was removed from service and replaced.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

• 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: 7725621
• MDR Text Key: 115194863
• Report Number: 2124215-2018-13650
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534553
• UDI-Public: (01)00802526534553(17)20170729
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/10/2018

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: 07/29/2017
• Device Model Number: G141
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 05/12/2018
• Initial Date FDA Received: 07/27/2018
• Supplement Dates Manufacturer Received: 08/10/2018
• Supplement Dates FDA Received: 10/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2015
• 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: 0184; 4046; 4469; 4525; 4592; G141; H175; MISMATCH; N118
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 71 YR