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

Model Number U128

Device Problems Premature Discharge of Battery (1057); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 03/30/2018

Event Type  malfunction  

Manufacturer Narrative

The product has been received for analysis. This report will be updated upon completion of analysis.

Event Description

Boston scientific received information that this cardiac resynchronization therapy pacemaker (crt-p) recorded an error indicative of low battery capacity during a pre-implant status. A request was made to have this device returned for analysis. The device was not implanted. No patient involvement.

Manufacturer Narrative

This device was thoroughly inspected and analyzed upon receipt at our quality assurance laboratory. Review of the device memory indicated that a telemetry system and battery system fault were recorded. Electrical testing and analysis isolated the product performance issue to an anomaly in the radio frequency (rf) mics module. This anomaly resulted in high power usage that depleted the battery while still in pre-implant status.

• 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: 7650530
• MDR Text Key: 112734330
• Report Number: 2124215-2018-11691
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 07/12/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/15/2018
• Device Model Number: U128
• Other Device ID Number: VALITUDE X4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: No Information
• Date Manufacturer Received: 07/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial