ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) OCTRODE LEAD KIT, 60CM LENGTH; SCS LEAD
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Model Number 3186 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Infection (1930)
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Event Date 11/12/2021 |
Event Type
Injury
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Manufacturer Narrative
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Event date is an estimate.
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Event Description
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Related manufacturer report number: 3006705815-2021-05900, 1627487-2021-18560, and 1627487-2021-18561.It was reported the patient¿s system was explanted due to infection concerns.The patient will be re-implanted on a later date.
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Manufacturer Narrative
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Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
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