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

Model Number U125

Device Problems High impedance (1291); Over-Sensing (1438); Pacing Problem (1439); Ambient Noise Problem (2877)

Patient Problem Syncope (1610)

Event Date 05/22/2018

Event Type  Injury  

Manufacturer Narrative

At this time, the product remains in-service. If additional information is received, this report will be updated.

Event Description

Boston scientific received information that this cardiac resynchronization therapy pacemaker (crt-p) and right ventricular (rv) lead had in-range spikes in impedance, where on two occasions it had caused respiratory trend oversensing with pacing inhibition greater than two seconds. The most recent episode caused the patient to become syncopal. The thresholds were within normal limits. The rrt trends were turned off in response. The system remains in-service. 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: 7725909
• MDR Text Key: 115207011
• Report Number: 2124215-2018-13200
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/19/2018
• Device Model Number: U125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: No Information
• Date Manufacturer Received: 06/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 07/27/2018 Patient Sequence Number: 1

Treatment

4136; 4137; 4457; 4554; H120; S606; U125