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

Model Number U128

Device Problems Failure to Capture (1081); Pocket Stimulation (1463); Low impedance (2285); Defective Device (2588)

Patient Problem Muscle Stimulation (1412)

Event Date 04/27/2018

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 a left ventricular (lv) lead revision procedure was performed due to pocket stimulation.It was noted that the day prior to the procedure the right ventricular (rv) lead had been programmed to unipolar configuration due to low pacing impedance measurements.The rv lead was also programmed sub threshold at that time.It was noted that the lv and rv leads were inspected under x-ray in the lab and found to be in good condition.Following the lv lead revision procedure noise was noted on the rv channel.Since the rv lead continued to exhibit low impedance measurements around 201 ohms and loss of capture (loc), another revision procedure was performed where the rv lead was surgically abandoned and successfully replaced.The crt-p remains 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: 7725528
• MDR Text Key: 115189243
• Report Number: 2124215-2018-13351
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559402
• UDI-Public: 00802526559402
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/14/2019
• Device Model Number: U128
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 04/27/2018
• Initial Date FDA Received: 07/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2017
• 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: 4470; 4671; H120; MISMATCH; U128
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 77 YR