MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND ACCOLADE; IMPLANTABLE PULSE GENERATOR

Model Number L101

Device Problems Low impedance (2285); Device Operates Differently Than Expected (2913); Device Sensing Problem (2917)

Patient Problems Chronic Obstructive Pulmonary Disease (COPD) (2237); Respiratory Failure (2484); No Known Impact Or Consequence To Patient (2692)

Event Date 02/08/2018

Event Type  malfunction  

Manufacturer Narrative

This investigation will be updated should further information be provided.

Event Description

Boston scientific received information that this patient presented to the emergency room with pulseless electrical activity (pea).Further review noted that on this pacemaker, there was an alert to check the right ventricular (rv) lead.There were out of range intrinsic amplitudes and a slight decrease in pace impedances on the rv observed.At this time, the products remain in service.The exact cause of the pea was not determined.No adverse patient effects were 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 which indicated the cause of the pea was determined.The patient had gone into respiratory failure due to chronic obstructive pulmonary disease (copd).The pacemaker and rv lead were operating appropriately.No adverse patient effects were reported.

• Brand Name: ACCOLADE
• Type of Device: IMPLANTABLE PULSE 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: 7362099
• MDR Text Key: 103190844
• Report Number: 2124215-2018-05267
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526558924
• UDI-Public: 00802526558924
• Combination Product (y/n): N
• PMA/PMN Number: N970003/S167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/16/2017
• Device Model Number: L101
• Other Device ID Number: ESSENTIO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 02/08/2018
• Initial Date FDA Received: 03/22/2018
• Supplement Dates Manufacturer Received: 03/28/2018
• Supplement Dates FDA Received: 04/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2015
• 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: 4457; 4470; L101
• Patient Age: 82 YR