Model Number 3660 |
Device Problem
Premature End-of-Life Indicator (1480)
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Patient Problems
No Consequences Or Impact To Patient (2199); Inadequate Pain Relief (2388)
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Event Date 08/21/2019 |
Event Type
Injury
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Manufacturer Narrative
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The results/method and conclusion codes along with investigation results will be provided when the evaluation is completed.
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Event Description
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It was reported the patient's scs system controller displayed "generator unavailable" message.Troubleshooting performed with technical services indicated the patient's scs ipg was had reached its end of service.It was undetermined if the issue was true end of service or premature battery depletion.Surgical intervention may be necessary to replace the patient's scs ipg.
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Event Description
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Follow up information received identified the patient's scs ipg was successfully replaced and therapy restored postoperative.
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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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Search Alerts/Recalls
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