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

Model Number G156

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

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

Event Date 04/01/2018

Event Type  malfunction  

Manufacturer Narrative

At this time, the product remains in service.If additional information is received, this report will be updated.

Event Description

Boston scientific received information that during this new cardiac resynchronization therapy defibrillator (crt-d) implant, the right ventricular (rv) shock lead impedance was measuring around 40 ohms.A couple days later, a invalid data message was observed.During a clinic visit the next day, the sli measurement was greater than 200 ohms.Daily measurements and sensing were consistent.The following day, measurements were in the 40's.Boston scientific technical services (ts) requested a memory dump, for evaluation.However, the physician was comfortable that it was a random measurement error.The cause remains unknown.No adverse patient effects were reported.

• Brand Name: DYNAGEN
• 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: 7614609
• MDR Text Key: 111646887
• Report Number: 2124215-2018-08343
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534669
• UDI-Public: 00802526534669
• 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
• Report Date: 04/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/09/2019
• Device Model Number: G156
• Other Device ID Number: DYNAGEN 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: 04/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2017
• 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: 89 YR