Model Number 3383 |
Device Problems
High impedance (1291); Low impedance (2285)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/05/2019 |
Event Type
Injury
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Manufacturer Narrative
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Investigation results will be provided in the final report.
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Event Description
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Device 1 of 2.Related manufacturer reference number: 1627487-2019-08027.It was reported that the patient was experiencing impedance problems.The patient had both low and high impedance readings.As a result surgical intervention took place on (b)(6) 2019 wherein the physician explanted and replaced the patient¿s extensions only.Therapy has been restored post-op.
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Manufacturer Narrative
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The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Event Description
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Device 1 of 2.Related manufacturer reference number: 1627487-2019-08027.
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Search Alerts/Recalls
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