Model Number 3660 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Pain (1994)
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Event Date 10/17/2017 |
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 1 of 2.Reference mfr.Report#:1627487-2017-08796.It was reported the patient experienced pain at the ipg site.As a result, the physician cleaned the pocket site, but no signs of infection were present.The physician relocated the ipg pocket site and replaced the patient¿s ipg with a new model on (b)(6) 2017.Postoperatively, effective therapy was reported.Note: both of the patient's ipgs are being reported because it is unknown which ipg is liable.
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Manufacturer Narrative
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Correction: ipg with serial (b)(4) associated with mfr.Report#: 1627487-2017-08785 was not explanted (b)(6) 2017, as it was not the ipg liable for the complaint.
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Event Description
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Device 1 of 2, reference mfr.Report#:1627487-2017-08796.
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Search Alerts/Recalls
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