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 07/09/2018

Event Type  malfunction  

Manufacturer Narrative

The local area field representative was contacted for additional information.At this time, no further information is available.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 initial implant of this cardiac resynchronization therapy defibrillator (crt-d) and right ventricular (rv) lead the rv lead exhibited fluctuations in r-wave measurements.The threshold and impedance measurements were good.However, during pocket closure there was oversensing of noise on the rv channel of the crt-d every few minutes.This oversensing resulted in brief periods of pacing inhibition.The patient was instructed to take deep breaths, but this did not reproduce the noise.An x-ray was also done, but did not reveal anything.Boston scientific technical services (ts) discussed that it may be due to air bubbles in the header which usually dissipate within 24 hours.The patient will stay in the hospital overnight and the crt-d system will be checked again in the morning.This product 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: 7984064
• MDR Text Key: 124341558
• Report Number: 2124215-2018-16663
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534904
• UDI-Public: (01)00802526534904(17)20200116
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/16/2020
• Device Model Number: G158
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 08/28/2018
• Initial Date FDA Received: 10/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2018
• 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: 0295; 4677; 7741; G158
• Patient Age: 63 YR