Model Number 97714 |
Device Problems
Shipping Damage or Problem (1570); Device Displays Incorrect Message (2591); Charging Problem (2892); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/31/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.
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Event Description
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The manufacturer representative (rep) reported that there was a power on reset (por).It was noted that prior to their case they were attempting to charge the implantable neurostimulator (ins), they had a difficult time getting recharger to connect with the ins even after moving antenna.They could not get any bars but finally after several tried a por code came up.The por was not successfully cleared.The ins was read with the clinician programmer and it never said a por had occurred; it just went to the screen to start the ins service life.It was confirmed that this was the first time they interrogated the ins with the clinician programmer since the por occurred.The rep tried again with the clinician programmer and they got the same screen so it was unknown what the code was associated with the por.The rep stated that the ins would be sent back for analysis.There were no symptoms reported.This occurred on (b)(6) 2016.
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Analysis of the ins, serial # (b)(4), found a parity por on a brand new device.A good faith effort will be made to obtain the applicable information relevant to the report.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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