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

Model Number U128

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

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

Event Date 11/09/2017

Event Type  Injury  

Manufacturer Narrative

The field representative was contacted to confirm if any further action would be taking place.At this time there is no further information available.If additional information becomes available, this report will be updated.

Event Description

Boston scientific received information that a health care professional (hcp) reported observing noise with this patient's cardiac resynchronization therapy defibrillator (crt-d) and competitor leads.Boston scientific technical services (ts) reviewed remote monitoring data and noted the right atrial (ra) lead impedances increased from 400 to 2532, then decreased again; with three lead safety switch activations.The right ventricular (rv) lead impedances were trending in the low 400 ohm range, with a single spike to 769 ohms.Several episodes showed myopotential noise on the ra, but the ra was programmed bipolar pace, unipolar sense.An additional episode from (b)(6) 2017 showed minute ventilation (mv) oversensing on the rv channel with a 9 second duration.The patient does not have an underlying rhythm.The respiratory rate trend (rrt) was programmed off.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: 7195009
• MDR Text Key: 97366378
• Report Number: 2124215-2017-22843
• 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
• Source Type: company representative
• Type of Report: Initial
• Report Date: 11/21/2017

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: 12/16/2017
• Device Model Number: U128
• Other Device ID Number: VALITUDE X4
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 11/21/2017
• Initial Date FDA Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2015
• 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: 5076; ADDRL1; MISMATCH; U128
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 84 YR