ACCOLADE

MDR report key: 5373001 · Received January 17, 2016

Report

Report Number: 2124215-2015-16332
Event Type: Malfunction
Date Received: January 17, 2016
Date of Event: November 17, 2015
Report Date: January 12, 2016
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: LWP
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NV, US
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

Additional Manufacturer Narrative · 1

UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A REVIEW OF THE DEVICE MEMORY NOTED THAT THE DEVICE DID NOT SET ANY FAULT CODES (FC). A RED SCREEN INDICATES THAT THE PROGRAMMER ISSUED THE FC(B)(4). A REVIEW OF THE TEMPERATURE MEASUREMENTS IN MEMORY, NOTED FIVE MEASUREMENTS AT OR BELOW 0 DEGREE C, ALL NOTED IN (B)(6) 2015. THE BATTERY VOLTAGES TRACKED WITH THE TEMPERATURES. ANALYSIS OF THE MEMORY INDICATES THAT THE FC(B)(4) WAS INDUCED BY EXPOSURE TO COLD TEMPERATURE BELOW LABELING (0 DEGREE C) WHILE IN THE SHIPPING BOX. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE RECORDED A CODE 1003 INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY PRIOR TO IMPLANT. THIS DEVICE WAS NEVER IN SERVICE AND WAS RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

Description of Event or Problem · 1

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
31999	ACCOLADE	IMPLANTABLE PULSE GENERATOR	LWP	GUIDANT CRM CLONMEL IRELAND	L301

Patients

Seq	Age	Sex	Outcome	Treatment
1