Model Number W1TR04 |
Device Problem
Reset Problem (3019)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/12/2018 |
Event Type
Injury
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Manufacturer Narrative
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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 the cardiac resynchronization therapy pacemaker (crt-p) exhibited a power on reset (por) with a diagnostic reset.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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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received, which indicated the device was interrogated the day after the por was observed and no reprogramming took place.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 the battery measurement was not available.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received, which indicated the device exhibited another power on reset (por).The device remains in use and no actions were taken.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received, which indicated multiple ride-through power on resets (por) were observed.It was noted once the patient is able to go into the clinic, the device will be interrogated and a software update will be provided.The device 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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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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Search Alerts/Recalls
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