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

Model Number G141

Device Problems High impedance (1291); Capturing Problem (2891); Device Operates Differently Than Expected (2913)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 08/01/2017

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 this cardiac resynchronization therapy defibrillator (crt-d) triggered an alert for high out of range pace impedances on the right ventricular (rv) lead.Further review noted there was one spike to out of range values of 2414 ohms a few months prior, and recently, they were greater than 3000 ohms.Besides the two spikes, the values were stable and within normal limits.At this time, the products remain in service.The rv lead is a competitor's product.No adverse patient effects were reported.

Event Description

Additional information was received which indicated the impedances had spiked to greater than 3000 ohms again at the end of (b)(6).The same tests were repeated and once the patient's arms were risen, the impedances were, again, out of range.This time, a deflection on the rate sense channel was observed, but the cause was not determined as it was quick and could not be reproduced.In addition, high pacing thresholds were also observed when the impedances rose.The thresholds went from 0.6v at 0.4ms to 1.3v at 0.4ms.When the patient's arms were lowered, all measurements were stable.The outputs were programmed to 3.5v at 0.4ms and the patient is being monitored.Boston scientific technical services attended the device check and suspected that the cause of the observations was likely to be related to underinsertion or spring contact connections.At this time, all products remain in service and there have been no adverse patient effects reported.

Event Description

Additional information was received which indicated the patient was brought in for further evaluation.An increase in rv impedances to 1800-2300 ohms was reproduced when the patient rose their arms above their head.Once the patient's arm were lowered, values were stable around 550 ohms.However, it was noted that the impedances have spiked twice since the out of range values to 1796 ohms and 1470 ohms.The left ventricular (lv) pace impedances were also observed to have gradually risen, but values remain within normal limits.At this time, the products remain in service and the patient will continue to be monitored.Both leads are a competitor's product.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: 7196649
• MDR Text Key: 97756905
• Report Number: 2124215-2018-00035
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534553
• UDI-Public: 00802526534553
• Combination Product (y/n): N
• PMA/PMN Number: P010012/S341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/28/2018

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: 04/28/2018
• Device Model Number: G141
• Other Device ID Number: INOGEN CRT-D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 12/06/2017
• Initial Date FDA Received: 01/16/2018
• Supplement Dates Manufacturer Received: 02/07/2018; 02/28/2018
• Supplement Dates FDA Received: 04/11/2018; 04/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2016
• 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
• Patient Age: 79 YR