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

Model Number G154

Device Problems Over-Sensing (1438); Low impedance (2285); Ambient Noise Problem (2877); Device Operates Differently Than Expected (2913); Device Sensing Problem (2917)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 09/23/2017

Event Type  Injury  

Manufacturer Narrative

No additional information is available.If additional information becomes available, this report will be updated at that time.

Event Description

Boston scientific received information that this cardiac resynchronization therapy defibrillator (crt-d) system detected an out of range atrial intrinsic amplitude measurement and an out of range atrial pacing impedance measurement of less than 200 ohms.The stored episodes were reviewed, and it was noted there were multiple atrial tachy response (atr) episodes due to inappropriate noise detection.No pacing inhibition of greater than 2 seconds noted.The root cause for the clinical observations remains undetermined.Technical services recommended an in-office check to further evaluate the device system.Additional information was received that the patient was seen in the clinic.Two episodes were reviewed, and were suggestive of ventricular tachycardia (vt).During one of the vt episodes, patient experienced tunnel vision and felt like he was going to pass out.The patient further explained it felt like when he previously had cardiac arrest.It was noted the associated right ventricular (rv) and left ventricular (lv) leads were stable.The decision was made to reprogram the atr duration, increase the atrial amplitude to 2.2 v, increase the atrial sensitivity to 1.5 mv and increase the lv amplitude to 2.9 v.The physician also changed the vt zone from 185 beats/minute to 150 beats/minute.The associated right atrial (ra) lead may be replaced at a future date.At this time, this crt-d remains in service and there were no adverse patient effects reported.

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

Additional information was received that the associated right atrial (ra) lead was surgically abandoned and replaced due to noise, oversensing and intermittent low pacing impedances.The root cause for the clinical observations was not determined.This cardiac resynchronization therapy defibrillator (crt-d) remains in service.No additional 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: 7353852
• MDR Text Key: 102972925
• Report Number: 2124215-2018-03798
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534652
• UDI-Public: 00802526534652
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/20/2017
• Device Model Number: G154
• Other Device ID Number: DYNAGEN CRT-D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2015
• 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: 0158; 4087; 4513; G154; H175; N118
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 68 YR