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

Model Number G156

Device Problems High impedance (1291); Over-Sensing (1438); Ambient Noise Problem (2877); Connection Problem (2900); Device Operates Differently Than Expected (2913)

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

Event Date 02/26/2018

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 this local representative contacted boston scientific's technical services.The local representative was informed by the clinic nurse who reported a right atrial (ra) impedance alert from this patient's latitude home monitoring system of greater than 3000 ohms.A review of stored data showed nominal ra impedances of approximately 550 ohms with intermittent spikes to greater than 3000 ohms.Additionally, a review of stored data identified atrial tachycardia episodes that shows minute ventilation (mv) rrt-noise on the ra electrogram.The mfv rrt-noise was caused by high impedance.The high impedance could be due to a setscrew connection or primary non-boston scientific lead issue.Since the implant of this non-boston scientific ra lead is relatively new (2016), the technical service's consultant suspect that the root cause may be due to a connection issue.The technical service's consultant recommended that be be seen in-clinic and reprogram the respiratory-related trends off.Diagnostic testing should be performed on the ra lead during patient isometrics and pocket manipulation.Subsequently, boston scientific received information that this local representative contacted boston scientific's technical services.The local representative discussed this event from an historical perspective.The technical service's consultant reported that the respiratory related trends is programmed off.Patient isometrics were performed with the patient's left arm but no electrogram noise occurred.The physician has elected to continue monitoring the ra pacing impedance.All indicators point to a spring contact issue with the non-boston scientific ra lead.

• 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: 7362382
• MDR Text Key: 103288132
• Report Number: 2124215-2018-05085
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534669
• UDI-Public: 00802526534669
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 02/26/2018

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: 04/12/2018
• Device Model Number: G156
• Other Device ID Number: DYNAGEN X4 CRT-D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 02/26/2018
• Initial Date FDA Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2016
• 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
• Patient Age: 70 YR