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

Model Number U128

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

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

Event Date 11/27/2017

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 the remote home monitoring system issues an alert for high out of range impedance measurements of greater than 2000 ohms for the cardiac resynchronization therapy pacemaker (crt-p) and another manufacturer¿s right atrial (ra) lead where the lead safety switch (lss) was triggered. Review of the data found one higher impedance reading of 1400 ohms from four months earlier. Review of the logbook found inappropriately stored atrial tachy response (atr) episodes from noise due to unipolar configuration after the lss was triggered. Further review found one inappropriate atr due to oversensing of noise from the minute ventilation signal eight months earlier. The field representative noted that the rate response trend had already been programmed off in the crt-p as the patient is pacemaker dependent. Boston scientific technical services (ts) discussed possible causes of abrupt impedance changes. The field representative that she performed maneuvers and could not create noise and all lead measurement were good. Ts discussed the programming options and noted that the other manufacturer¿s rv lead currently is displaying stable impedance measurements. The crt-p and ra lead remain in service and no adverse patient effects were reported. This device was included in the recent mv 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: 7979854
• MDR Text Key: 124174960
• Report Number: 2124215-2018-14958
• Device Sequence Number: 1
• Product Code: NKE
• 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

• Type of Report: Initial
• Report Date: 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 10/26/2018
• Device Model Number: U128
• 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: 07/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2016
• 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: 10/18/2018 Patient Sequence Number: 1

Treatment

MISMATCH; U128