Model Number 3186 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Weight Changes (2607)
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Event Type
Injury
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Manufacturer Narrative
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In the event the device is returned to the manufacturer, the reported event cannot be analyzed via laboratory testing.The manufacturer has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.The manufacturer defers to the patient's physician regarding medical history.
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Event Description
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Device 4 of 4: reference mfr report: 1627487-2018-02418, reference mfr report: 1627487-2018-02419, reference mfr report: 3006705815-2018-00516.It was reported that the patient experienced pain at their anchor site.Reportedly the pain started after the patient lost weight.As a result, surgical intervention may be pending.
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Event Description
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Device 4 of 4, reference mfr report: 1627487-2018-02418; reference mfr report: 1627487-2018-02419; reference mfr report: 3006705815-2018-00516.Follow up revealed that the patient underwent surgical intervention to have their leads and anchors explanted.A new lead was implanted.Issue was resolved.
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Manufacturer Narrative
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Corrected data: patient, device, and initial reporter information was unintendedly incorrect in the initial report.This report contains correct information.
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Event Description
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Related manufacturer reference numbers# 1627487-2018-02418, 1627487-2018-02419, 3006705815-2018-00516.
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Manufacturer Narrative
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Correction: (b)(4).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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