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Model Number 5392 |
Device Problems
Corroded (1131); Mechanical Problem (1384)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/15/2019 |
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 the external pulse generator (epg) lower casing was corroded, damaged, and required replacement.The programmer was returned for service.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Product analysis: the complaint was confirmed.The battery compartment was found to be rusted, such that a positive battery terminal spring was broken off.Miscellaneous parts were found loose in the device.Output connector nuts were discolored.Two case screw were missing.Evidence was found of third-party maintenance of the device.All found defective parts were replaced and all other identified issues were resolved.The device was re-calibrated and functionally tested and it passed its final quality assurance tests.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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