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

Model Number G148

Device Problems High impedance (1291); Connection Problem (2900)

Patient Problems Death (1802); Renal Failure (2041); No Known Impact Or Consequence To Patient (2692)

Event Date 01/07/2016

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 during the post operative device interrogation, it was noted that the right ventricular (rv) pacing impedance measurement was greater than 3000 ohms with using the second electrode.Under fluoroscopy it was confirmed that the rv lead was under inserted into the header of the newly implanted cardiac resynchronization therapy defibrillator (crt-d).Since impedance measurements were within normal limits for electrode one, the physician opted to program the device and lead to use electrode one.The crt-d and rv lead remain in service and no adverse patient effects were reported.

Manufacturer Narrative

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Event Description

It was previously reported that during the post-operative device interrogation, the right ventricular (rv) pacing impedance measurement was greater than 3000 ohms an under fluoroscopy the rv lead was found to be under inserted into the header of the newly implanted cardiac resynchronization therapy defibrillator (crt-d).However, upon further review it was actually that another manufacturer's quadrapolar left ventricular (lv) lead that exhibited the high out of range pacing impedance measurements of 3000 ohms and was found to be under inserted in the header of the crt-d.Since impedance measurements were within normal limits when programmed with a different electrode combination, the physician opted to program the device and lead to use the different electrode combination.The crt-d and lv lead remain in service and no adverse patient effects were reported.Further information was received several months later that the patient passed away approximately one month post implant as a result of kidney failure.From the physician's prospective, the issue encountered at implant did not cause or contribute to the patient's death.The field representative reported that the device was not available for return.

• 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: sonali vasekar ; 4100 hamline ave. n; st. paul, MN ; 6515824786
• MDR Report Key: 5595904
• MDR Text Key: 43275416
• Report Number: 2124215-2016-01306
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534591
• UDI-Public: (01)00802526534591(17)20171022
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 01/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/22/2017
• Device Model Number: G148
• Other Device ID Number: INOGEN X4 CRT-D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 01/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2015
• 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
• Patient Age: 64 YR