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

Model Number U128

Device Problems Failure to Capture (1081); Impedance Problem (2950)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/20/2018

Event Type  malfunction  

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 the left ventricular (lv) lead connected to this pacemaker, triggered an alert, which indicated that the pacing impedance greater than 2000 ohms. As programmed, the pacing configuration switched from bipolar to unipolar. However, the lead did not have capture, in this configuration. The health care professional (hcp) did not want this to happen again and thus turned off the alert. Once the lv lead was programmed back to it's original configuration, impedance was about 1400 ohms and threshold was 0. 9 volts at 0. 1 milliseconds. The physician was informed and decided that since the right ventricular (rv) lead remains fine and threshold is good on the lv lead, the patient will be monitored. 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: 7616732
• MDR Text Key: 111647085
• Report Number: 2124215-2018-07457
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• PMA/PMN Number: P030005/S113
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/22/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 09/17/2018
• Device Model Number: U128
• Other Device ID Number: VALITUDE X4
• 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: 04/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial