Model Number SC-1112 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bacterial Infection (1735); Fever (1858); Sepsis (2067); Swelling (2091)
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Event Date 12/21/2017 |
Event Type
Injury
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Manufacturer Narrative
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The explanted devices were not returned to bsn as they were discarded by the medical facility.The model number and serial numbers of the explanted lead or leads is currently unknown.
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Event Description
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A report was received that the patient was experiencing dizziness, fever and a swollen face.The physician assessed that the patient had a non-device related infection and sepsis in the blood.The patient was hospitalized and was assessed to be in serious condition.The patient was administered antibiotics and an explant of the entire system was conducted.
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Manufacturer Narrative
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Additional suspect medical device components involved in the event: model: sc-2352-70 serial/lot: (b)(4) description: linear 3-4 lead, 70cm model: sc-4318 serial/lot: (b)(4) descripcription: clik x anchor 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 was experiencing dizziness, fever and a swollen face.The physician assessed that the patient had a non-device related infection and sepsis in the blood.The patient was hospitalized and was assessed to be in serious condition.The patient was administered antibiotics and an explant of the entire system was conducted.
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Search Alerts/Recalls
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