Model Number SC-2316-50 |
Device Problems
Device Issue (2379); Impedance Problem (2950)
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Patient Problems
Inadequate Pain Relief (2388); No Known Impact Or Consequence To Patient (2692)
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Event Date 04/18/2017 |
Event Type
Injury
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Event Description
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A report was received that the patient underwent a lead explant procedure due to an unknown reason.
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Manufacturer Narrative
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Additional information was received that no further information can be obtained.
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Event Description
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A report was received that the patient underwent a lead explant procedure due to an unknown reason.
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Manufacturer Narrative
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Additional information was received that the patient experienced inadequate stimulation as there were high impedances on most of the contacts on the leads.Additional suspect medical device component involved in the event: model #: sc-2316-50 serial #: (b)(4)description: infinion 16 lead kit 50 cm the explanted leads were not returned to bsn.A review of the manufacturing documentation for the leads revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.
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Event Description
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A report was received that the patient underwent a lead explant procedure due to an unknown reason.
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Search Alerts/Recalls
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