Model Number W4TR01 |
Device Problems
Incorrect Measurement (1383); Unable to Obtain Readings (1516); Inappropriate or Unexpected Reset (2959)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/08/2018 |
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 a partial power on reset (por) was observed on the cardiac resynchronization therapy pacemaker (crt-p).The parameters were unchanged with invalid ventricular sensing episodes noted.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 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 patient was seen following the por and the ventricular safety pace response was programmed off.The device remains in use.No patient complications have been reported as a result of this event.
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Search Alerts/Recalls
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