Model Number W4TR01 |
Device Problem
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 05/15/2019 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: 4076-52 lead; 4076-58 lead, implanted: (b)(6) 2016.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 ride through power on reset (por).A device update, delivered via in-clinic interrogation, was recommended by the manufacturer.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 rate and ventricular rate histograms 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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It was later confirmed the device was updated with an in-clinic interrogation.
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Search Alerts/Recalls
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