MEDTRONIC EUROPE SARL PERCEPTA QUAD CRTP; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION
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Model Number W4TR04 |
Device Problem
Incorrect Measurement (1383)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/17/2018 |
Event Type
malfunction
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Manufacturer Narrative
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This device was reported as included in the field action.Based on the information received and without the return of the product, it cannot be confirmed that this device performed as described in the field action.It is included in the field action in the abundance of caution.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that during an interrogation the cardiac resynchronization therapy pacemaker (crt-p) displayed an error message indicating the ventricular sensing episodes list contained invalid data.The crt-p remains in use.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Product event summary: the device was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated a software error.Analysis of the device memory indicated that the atrial and ventricular rate histogram data were missing/invalid.Analysis of the device memory indicated an issue with missing/invalid diagnostic data.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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