Model Number SC-1132 |
Device Problem
No Apparent Adverse Event (3189)
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Patient Problems
Bacterial Infection (1735); Patient Problem/Medical Problem (2688)
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Event Date 05/08/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Additional suspect medical device components involved in the event: model#: sc-2218-70, serial#: (b)(4), description: linear st lead, 70cm; model#: sc-4316, serial#: (b)(4), description: next generation anchor kit-sterile.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 was rejecting the devices.The patient underwent an explant procedure.No device malfunction was suspected.
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Manufacturer Narrative
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Additional information was received that the explant procedure was due to the patient's state of health.
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Event Description
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A report was received that the patient's body was rejecting the devices.The patient underwent an explant procedure.No device malfunction was suspected.
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Manufacturer Narrative
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Additional information was received that the explant procedure was due to the patient's state of health.It was also noted that the patient had an infection at ipg site.
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Event Description
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A report was received that the patient's body was rejecting the devices.The patient underwent an explant procedure.No device malfunction was suspected.
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Manufacturer Narrative
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It should have been 06-jun-2016 additional information was received that the physician did not believe the infection at the ipg site was device or procedure related.The patient had another infection in her body.The patient was administered antibiotics.No further information can be obtained.Sc-1132, s/n (b)(4): the source of the infection was not determined.Review of the sterilization record did not find any anomalies or deviations that potentially relate to the reported event.The device functionality test was performed to ensure the device integrity.No anomalies were found.
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Event Description
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A report was received that the patient's body was rejecting the devices.The patient underwent an explant procedure.No device malfunction was suspected.
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Search Alerts/Recalls
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