October 2021 : Abbott Assurity and Endurity pacemaker (our ref. FA-Q121-CRM-2) : For a subset of Assurity and Endurity Pacemakers
Abbott Assurity and Endurity pacemaker (our ref. FA-Q121-CRM-2) : For a subset of Assurity and Endurity Pacemakers
Affected Medical Device : Assurity and Endurity Pacemaker
MDA Reference Number : MDA/FCA/2021-P141
MDA Registration Number :
GD71875822118
GD64888496517
Decription :
Abbott has deployed a new Electronics Performance Indicator (EPI) tool to assist in patient management in patients followed with Merlin.net. The EPI tool supplements ERI using data available on Merlin.net to identify abnormal electrical system behavior resulting from loss of hermeticity. The EPI tool estimated sensitivity is 87% (ability to detect abnormal electrical system behavior of this nature) and estimated specificity is > 99.9%. The EPI tool has been designed to provide earlier indication, with detection occurring on average 6 weeks before an interruption of a device function (e.g. loss of telemetry / communication, etc.). The EPI tool is an Abbott surveillance process that reviews data from all devices within the affected population communicating with Merlin.net. If an EPI signal is detected, Abbott will notify the clinic using the email contact information in Merlin.net.
Local Establishment Contact Detail :
Sharon Wong
Seniour QA Specialist SEA
Abbott Medical (M) Sdn. Bhd.
No. 22, Jalan Pemaju U1/15, Seksyen U1, HICOM-Glenmarie Industrial Park, 40150 Shah Alam, Selangor, Malaysia
O: +6 03 5566 3487
Email : [email protected]
