Model Number 3228 |
Device Problems
Disconnection (1171); Insufficient Information (3190)
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Patient Problems
Inadequate Pain Relief (2388); Insufficient Information (4580)
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Event Date 03/25/2021 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.During processing of this complaint, attempts were made to obtain weight but not received.
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Event Description
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Related manufacturer reference number 3006705815-2021-01623.It was reported the patient's system was explanted and replaced for an unknown reason.
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Manufacturer Narrative
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D6b - date of explant should have been (b)(6) 2021 instead of (b)(6) 2021.The results of the investigation are inconclusive since the devices were not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.
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Event Description
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Additional information was received some of the contacts are out of the paddle and in return patient experienced ineffective therapy.
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Search Alerts/Recalls
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