ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) OCTRODE LEAD KIT, 60CM LENGTH; PERCUTANEOUS LEAD
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Model Number 3186 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/24/2021 |
Event Type
Injury
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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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Event Description
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Related manufacturer reference number: 3006705815-2021-02892.It was reported the patient experienced trouble breathing during the patient's permanent implant surgery on (b)(6) 2021.As a result, one of the leads which was already implanted (sn: (b)(4)) was explanted, and another lead that was yet to be implanted (sn: (b)(4)) was discarded.The procedure was abandoned with no devices implanted.
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Search Alerts/Recalls
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