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

Model Number L121

Device Problems Failure to Capture (1081); High impedance (1291); Over-Sensing (1438); Pacing Problem (1439); Ambient Noise Problem (2877)

Patient Problem Syncope (1610)

Event Date 05/29/2018

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

It was reported that the patient had a heart rate of 37 beats per minute (bpm), when the lower rate limit was programmed at 40 bpm.Technical services discussed possible causes.The healthcare provider health care professional (hcp) was going to bring the patient in, to learn all the parameters.Additional information was reported, indicating that there was a loss of capture (loc) at 5 volts (v), on the right ventricular (rv) epicardial lead from another manufacturer.However, current threshold was 0.8 v.The field representative stated that the clinic programmed the lead configuration to unipolar pace and bipolar sense, and left the output at 5v at 0.4 milliseconds.There was an occasional loc still observed.There were also reportedly some random pace impedance spikes, thus the minute ventilation (mv)feature was programmed to off.Data analysis revealed that the pace impedance spikes were within normal limits and there were no device issues.Further review of the previous electrograms (egm) revealed noise oversensing as a result of the mv feature.At one point, the patient had reportedly experienced a 14 second pause.This occurred prior to the device reprogramming.No additional adverse patient effects were reported.This device was included in the recent minute ventilation sensor signal oversensing advisory population.

• 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: 8048597
• MDR Text Key: 126495791
• Report Number: 2124215-2018-19393
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526558986
• UDI-Public: 00802526558986
• 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: 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/23/2019
• Device Model Number: L121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 09/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0368-2018
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 34 YR