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

Model Number U125

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

Patient Problems Headache (1880); Unspecified Infection (1930); Dizziness (2194)

Event Date 07/21/2017

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 this cardiac resynchronization therapy pacemaker (crt-p), left ventricular (lv) and another manufacturer's right ventricular (rv) lead exhibited high out of range pacing impedance measurements greater than 2,000 ohms resulting in activation of the lead safety switch (lss) feature.Review of stored device memory also noted several stored ventricular tachycardia (vt) episodes due to noise and oversensing on both leads that was felt to be consistent with oversensing related to the respiratory rate trend (rrt) feature.The patient was noted to be pacemaker dependent and experienced pacing inhibition for greater than 10 seconds of asystole.The patient also complained of symptoms of lightheadedness, dizziness and headaches.It was noted that the patient had recently been diagnosed with a sinus and respiratory infection, so it was unknown if the symptoms were related to the illness or the device and leads.A chest x-ray was performed and noted no obvious anomalies.Boston scientific technical services (ts) discussed programming rrt off.Programming changes were made to rv and lv lead sensitivity and monitoring will be continued.No adverse patient effects were reported.This product remains implanted and in service.

• 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: 7191784
• MDR Text Key: 97294068
• Report Number: 2124215-2017-20630
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559389
• UDI-Public: 00802526559389
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/22/2018
• Device Model Number: U125
• Other Device ID Number: VALITUDE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2016
• 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
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 78 YR