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

Model Number G158

Device Problems Over-Sensing (1438); Pacing Problem (1439); Ambient Noise Problem (2877)

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

Event Date 05/09/2018

Event Type  Injury  

Manufacturer Narrative

The device remains in service at this time.If additional information is received, this report will be updated.

Event Description

Boston scientific received information that this cardiac resynchronization therapy defibrillator (crt-d) exhibited right ventricular (rv) noise, oversensing, and pacing inhibition with a pause in pacing greater than three seconds.There was also noise on the shock channel.It was discussed that the noise appeared to be due to electromagnetic interference (emi).All lead measurements were stable.The sensitivity was reprogrammed and the patient would follow up with their physician.No additional adverse patient effects were reported.The device remains in service.

• 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: 7755710
• MDR Text Key: 116204659
• Report Number: 2124215-2018-14254
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534904
• UDI-Public: 00802526534904
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/06/2018
• Device Model Number: G158
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 05/25/2018
• Initial Date FDA Received: 08/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2016
• 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: 0292; 4675; 7741; G158
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR