Model Number 3189 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Wound Dehiscence (1154); Impaired Healing (2378)
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Event Date 06/30/2016 |
Event Type
Injury
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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.(b)(4).
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Event Description
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Device 1 of 3: reference mfr report: 1627487-2016-03830, reference mfr report: 1627487-2016-03843.The patient has two anchors with the same lot number.It was reported the patient's cervical lead incision is not healing properly and is still open.The physician stated the patient may be reacting to the anchor.Surgical intervention may be pending to address the issue.
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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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Event Description
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Device 1 of 3 reference mfr report: 1627487-2016-03830.Reference mfr report: 1627487-2016-03843.Follow up information identified the patient's physician suspects the wound did not close due to an allergy.The patient's entire scs system was removed and the incision site is healing well.
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Search Alerts/Recalls
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