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

Model Number L311

Device Problems Failure to Capture (1081); Capturing Problem (2891)

Patient Problem Pneumonia (2011)

Event Date 03/03/2018

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 while the patient was in the hospital for pneumonia the field representative was called to perform an interrogation on the pacemaker.Upon interrogation it was found that the right ventricular (rv) lead threshold measurements had increased and there was intermittent loss of capture (loc).The patient did have an underlying rhythm, but the rate was unknown.The output was reprogrammed to provide an appropriate safety margin.Boston scientific technical services (ts) suggested an x-ray, however the field representative noted that he was not aware of them ordering one.The pacemaker and rv lead remain in service and no additional 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: 7409270
• MDR Text Key: 104768432
• Report Number: 2124215-2018-06298
• Device Sequence Number: 1
• Product Code: LWP
• 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: 03/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/25/2019
• Device Model Number: L311
• Other Device ID Number: ACCOLADE MRI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2017
• 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: 4456; 4479; 7740; L311
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 86 YR