Model Number 3788 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Impaired Healing (2378)
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Event Date 04/24/2015 |
Event Type
Injury
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Event Description
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Device 1 of 2 reference mfr.Report #1627487-2015-06278 additional information received identified surgical intervention took place on (b)(6) 2015 at which time the patient's ipg as well as lead were explanted as both wounds were not healing properly.The patient was then implanted with a new lead and ipg in a different location.The patient's incisions are reportedly healing well.The patient will continue to be monitored by her physician.
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Event Description
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It was reported the patient's scs ipg incision site is not healing properly but there are no signs of infection at this time.Surgical intervention is planned for a later date to relocate the patient's ipg pocket.
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Event Description
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Device 1 of 2 reference mfr.Report #1627487-2015-06278 additional information received identified the patient's incision has reportedly healed.
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Manufacturer Narrative
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(b)(4).Sjm 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.Sjm defers to the patient's physician regarding medical history.
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Manufacturer Narrative
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Sjm 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.Sjm defers to the patient's physician regarding medical history.
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Manufacturer Narrative
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Sjm 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.Sjm defers to the patient's physician regarding medical history.
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Search Alerts/Recalls
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