MEDTRONIC MILACA, INC. DUAL CHAMBER TEMPORARY PACEMAKER; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
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Model Number 5388 |
Device Problems
Power Problem (3010); Unexpected Shutdown (4019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/04/2021 |
Event Type
malfunction
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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 when the external pulse generator (epg) was on and the battery was then removed, the time taken for the epg to shut off was inconsistent from 0-10 seconds.No patient complications have been reported as a result of this event.
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Search Alerts/Recalls
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