Model Number SC-1110-02 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Impaired Healing (2378); Reaction (2414)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Date of event: (b)(6) 2012.Date of explant: (b)(6) 2012.Additional suspect medical device components involved in the event: model#: sc-2218-70 serial #: (b)(4) description: linear st, lead, 70cm the explanted devices were not returned to bsn.It is indicated that the devices will not be returned for evaluation; therefore a failure analysis of the complaint devices could not be completed.A review of the device history records will be conducted.If there is any further relevant information from that review, a supplemental med watch will be filed.
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Event Description
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A report was received that the patient's body rejected the scs device thus the patient underwent an explant procedure.
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Manufacturer Narrative
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Additional information was received that the patient's symptoms of the body rejecting the implants, were spinal irritation and swelling.No device malfunction was suspected.No further information can be obtained.
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Event Description
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A report was received that the patient's body rejected the scs device thus the patient underwent an explant procedure.
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Search Alerts/Recalls
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