Model Number W4TR04 |
Device Problems
Inappropriate or Unexpected Reset (2959); Reset Problem (3019)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/19/2018 |
Event Type
malfunction
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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.This device was reported as included in the field action noted and returned product investigation found the device performed as described in the field action.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Concomitant medical products: 4598 lead, implanted: unknown.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) experienced a partial electrical reset.The crt-p remained in use and no intervention was taken.It further reported that two days later the crt-p experienced an additional partial electrical reset.The crt-p will be reprogrammed and 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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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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