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

Model Number G156

Device Problems High impedance (1291); Over-Sensing (1438); Pacing Problem (1439); Ambient Noise Problem (2877); Device Operates Differently Than Expected (2913)

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

Event Date 02/28/2018

Event Type  Injury  

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 this system was exhibiting noise, oversensing, pacing inhibition, increased shocking impedance measurements and pacing impedance measurements greater than 3000 ohms on the right ventricular (rv) channel.The issues noted on the rv channel started shortly after the patient had an av node ablation, upgrade procedure and a revision procedure shortly following the upgrade to secure the left ventricular (lv) lead in the device header due to pacing impedance measurements greater than 2000 ohms.The physician could not confirm if the rv lead had been manipulated during the lv lead revision.The reported issues could not be reproduced with in office testing and troubleshooting.Therefore, a revision procedure was performed and the lead was disconnected and reconnected to the device with normal impedance measurements and no observed noise.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: 7630949
• MDR Text Key: 112080560
• Report Number: 2124215-2018-11097
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534669
• UDI-Public: 00802526534669
• 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
• Report Date: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/16/2019
• Device Model Number: G156
• Other Device ID Number: DYNAGEN X4 CRT-D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 05/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2017
• 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
• Treatment: 0185; 4136; 4674; D143; E030; G156
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 58 YR