Model Number 3186 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Wound Dehiscence (1154); Hypersensitivity/Allergic reaction (1907)
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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 3 of 3, mfr report # 1627487-2018-01294, 1627487-2018-01293, it was reported that patient observed red bumps around ipg and lead incision sites possibly associated with either allergic reaction or infection two weeks after scs implant.As a result, patient was prescribed a sulfa antibiotic ointment.Subsequently, patient¿s wounds begin to open.Patient has stated rubbing the incision sites with bar soap.Patient was then prescribed oral antibiotics.Patient¿s symptoms are slowly improving.The patient may undergo further tests regarding the issue.Patient has effective therapy.
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Event Description
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Additional follow up revealed that infection was not confirmed.
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Event Description
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Device 3 of 3: reference mfr report: 1627487-2018-01293; reference mfr report: 1627487-2018-01294.Additional information received indicated the patient was referred to a dermatologist and it was determined the reaction was due to a topical gel.The issue has since resolved.
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Event Description
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Additional information was received that the allergic reaction did not actually resolve, and the patient had to undergo surgical intervention to explant the ipg.
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Manufacturer Narrative
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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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Search Alerts/Recalls
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