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Model Number 5392 |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/27/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Product analysis: at analysis it was determined that the display wires were pinched with the red wire exposed.It was noted that the upper case was cracked at the bosses, the lower case was cracked at the battery drawer and the main seal was damaged.All found defective parts were replaced and all other identified issues were resolved.The device then passed all final functional tests.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 external pulse generator (epg) was returned for repair, test and calibration.There was no patient involvement.It was further reported that the epg subsequently tested out of specification during manufacturer's analysis.
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Search Alerts/Recalls
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