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

Model Number U128

Device Problems Over-Sensing (1438); Pacing Problem (1439); Ambient Noise Problem (2877); Material Integrity Problem (2978)

Patient Problem Dizziness (2194)

Event Date 12/27/2017

Event Type  malfunction  

Manufacturer Narrative

No further information has been provided to date.This report will be updated should additional information become available.

Event Description

Boston scientific received information that this cardiac resynchronization therapy pacemaker (crt-p) and competitor right ventricular (rv) lead exhibited myopotential oversensing resulting in approximately 3 seconds of pacing inhibition.The noise occurred while the patient was carrying a heavy object and resulted in dizziness.Noise was reproducible when the patient mimicked the movement.Lead measurements were within normal limits and stable, however, insulation damage was still suspected.Boston scientific technical services (ts) provided programming recommendations.No adverse patient effects were reported.This system remains 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: 7238763
• MDR Text Key: 98997358
• Report Number: 2124215-2018-02353
• 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: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/10/2018
• Device Model Number: U128
• Other Device ID Number: VALITUDE X4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2016
• 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 Age: 70 YR