X
OK Your changes have been successfully saved
SFDA Home Page
Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 065 06 18 000
Date submitted: 6/17/2018
Manufacturer:Medtronic SA
Device Type:Single Chamber Temporary External Pacemaker 53401
Description:Pacemaker, cardiac, external, invasive
Medical Device Identifier:Affected devices include Model 53401 EPGs with serial numbers lower than MDB05000 that were distributed between February 2017 and November 2017.
Reason of Field Safety Corrective Action:The initial version of 53401 EPG firmware was configured to allow an unused, unterminated digital input/output pin to be an input. During investigation of this issue, this unterminated pin was found to act as an antenna, which could detect external electrical signals. The 53401 EPG microprocessor expects the unterminated pin to be silent. When this unterminated pin detects electrical signals, device firmware may lock up and cause a POR. When the EPG experiences a POR, by design, the device will cease functioning for approximately 7 seconds while it reboots, then resume functioning at nominal settings.
Remedy Action:Recently, Medtronic received approval for a firmware correction that prevents occurrence of this issue. Medtronic recommends customers send affected devices to Medtronic Service to update the firmware to prevent this issue.

1. Verify whether 53401 EPGs in your possession are affected

2. If your EPG is affected, complete the following:

o Determine if the EPG firmware has been updated.

- Power unit on and view firmware version (Figure 1 below).

- If firmware version is 01.03.00 or greater, EPG firmware has been updated with correction for this issue. No other action is recommended.

- If firmware version is 01.02.00, EPG firmware has not been updated. You may arrange to have your Medtronic Service Center update the EPG firmware at no charge.
Athorized Representative/Importer/Distributor:Medtronic Saudi Arabia
Report Source:NCMDR
Source Ref. Number:A95E18547A1ED
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Medtronic SA.pdf