Merlin PCS 3650 Pacemaker Programmer Software Anomaly May Cause Loss of Pacing
A software anomaly in Abbott's Merlin PCS 3650 programmer may prevent proper finalization of leadless pacemakers, causing loss of pacing function. The issue occurs when specific actions combine with brief telemetry loss.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II device recall involving a potential loss-of-function defect in a critical life-sustaining medical device. While no illnesses or injuries have been reported in the source text, loss of pacing function in a pacemaker could cause serious harm. Per the rubric, this constitutes a 'risk-of-harm product where injury has not yet been reported,' warranting a High (3) rating.
Plain-English summary
The Merlin PCS 3650 programmer is a portable device used to program and monitor implantable leadless pacemakers manufactured by Abbott Medical. Due to a software anomaly, a specific sequence of programmer actions combined with a brief loss of telemetry (less than 2 seconds) may cause the finalization step of the pacemaker setup to fail.
When this occurs, the programmer displays a 'loss of telemetry detected' message and the pacemaker stops pacing. This condition could result in inadequate cardiac output and serious patient harm.
Approximately 7,295 programmers have been distributed worldwide, including throughout the United States and multiple international locations. Affected patients should contact their healthcare provider or Abbott Medical to determine if their device is affected and discuss monitoring or management options.
The recalled product
- Product
- The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable
- Manufacturer
- Abbott Medical
- Affected units
- 7,295
Distribution
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