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

Model Number G151

Device Problems Failure to Capture (1081); High impedance (1291); Over-Sensing (1438); Ambient Noise Problem (2877)

Patient Problem Palpitations (2467)

Event Date 01/04/2018

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 patient with this cardiac resynchronization therapy defibrillator (crt-d) received inappropriate atrial tachy response (atr) due to noise and oversensing on the right atrial (ra) lead.In addition, the ra lead pacing impedances had intermittently spiked, however, they were still within normal limits.The patient experienced palpitations.The patient's ra lead was a non-boston scientific product.Boston scientific technical services (ts) discussed that the noise was respiratory rate trend (rrt) oversensing and recommended programming it off.They also mentioned there was questionable ra capture and recommended evaluating the lead.The electrogram (egm) indicated that the patient didn't experience greater than 2 seconds of asystole.The minute ventilation (mv) sensor was programmed off and the noise was immediately removed.This crt-d system remains in service.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: 7984165
• MDR Text Key: 124337734
• Report Number: 2124215-2018-16660
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534638
• UDI-Public: (01)00802526534638(17)20180719
• 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
• Report Date: 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/19/2018
• Device Model Number: G151
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 08/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2016
• 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
• Treatment: 0185; 4968; 5076; G151; MISMATCH
• Patient Age: 68 YR