Model Number 2090AA |
Device Problem
Unexpected Shutdown (4019)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/29/2018 |
Event Type
malfunction
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Manufacturer Narrative
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This device was reported as included in the field action. based on the information received and without the return of the product, it cannot be confirmed that this device performed as described in the field action.It is included in the field action in the abundance of caution. 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 programmer shut off twice during an implant procedure.The procedure was completed successfully despite the issue.The programmer is expected to be 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 programmer's power source was found to be out of electrical specification, and was replaced.The case was found to be damaged.Damaged components were replaced.The hard drive was reconfigured, the software was reloaded and updated, and the device passed all final functional and systems tests.This device was reported as included in the field action noted but returned product investigation found the device did not perform as described in the field action.The device is no longer included as part of the field action.If information is provided in the future, a supplemental report will be issued.
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Event Description
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2019-01-14: the programmer was returned for service.
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Search Alerts/Recalls
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